Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis (COBALT)

February 13, 2023 updated by: Intercept Pharmaceuticals

A Phase 4, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Patients With Primary Biliary Cholangitis

Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its hepatoprotective effects and result in attenuation of injury and improved liver function in a cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC participants.

Study Overview

Status

Terminated

Conditions

Liver Cirrhosis, Biliary

Intervention / Treatment

Detailed Description

This Phase 4, double-blind, randomized, placebo-controlled, multicenter study is being undertaken at up to 170 sites internationally to evaluate the effect of OCA on clinical outcomes in 428 participants with PBC. The study will include a screening period of up to 8 weeks, requiring two clinic visits. Eligible participants will be randomly allocated (1:1) to treatment with either OCA 5 mg or matching placebo tablets, taken orally once daily for the majority of participants; dose and frequency will be modified for participants with cirrhosis and classified as Child-Pugh (CP) B or C. Randomization will be stratified by standard treatment with UDCA (yes/no) and baseline liver function. The treatment period involves clinic visits approximately every 3 months. At the 3 month visit or any study visit thereafter, if study treatment is tolerated, participants' dose should be titrated per protocol in a blinded manner eg for participants who are non-cirrhotic or classified as CP A and randomized to OCA, they should receive the maximum daily dose of 10 mg OCA, those on placebo continue to receive placebo. Subsequently, daily dosage may return to 5 mg if necessary for these participants who are non-cirrhotic or classified as CP A, but should be increased to 10 mg if possible, based on tolerability and clinical judgment. Safety and tolerability will be assessed by monitoring adverse events and vital signs, and blood and urine testing. The study is event driven and total duration will be determined by the time required to accrue approximately 127 primary endpoint events, estimated to be approximately 10 years. Participants are expected to have a minimum follow-up time of approximately 6 years.

Study Type

Interventional

Enrollment (Actual)

334

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, 1119
    - CIPREC - Centro de Investigacion y Prevencion Cardiovascular S.A.
  - Buenos Aires, Argentina, 1120
    - Hospital De Clinicas University Of Buenos Aires
  - Buenos Aires, Argentina, 1425
    - Centrol Integral de Gastroenterologia
  - Ciudad Autónoma de Buenos Aires, Argentina, 1181
    - Hospital Italiano de Buenos Aires
  - Ciudad Autónoma de Buenos Aires, Argentina, 1264
    - Hospital de Gastroenterología Dr. Carlos Bonorino Udaondo
  - Ciudad Autónoma de Buenos Aires, Argentina, C1118AAT
    - Hospital Aleman
  - Ciudad Autónoma de Buenos Aires, Argentina, C1280AEB
    - Hospital Britanico de Buenos Aires
- Buenos Aires
  - La Plata, Buenos Aires, Argentina, B1902AWL
    - Centro de Hepatologia
  - Presidente Derqui, Buenos Aires, Argentina, 1629
    - Hospital Universitario Austral
  - Ramos Mejía, Buenos Aires, Argentina, 1704
    - Dim Clinica Privada
- Cordoba
  - Córdoba, Cordoba, Argentina, X5016KEH
    - Hospital Privado Universitario de Cordoba S.A.
- Santa Fe
  - Rosario, Santa Fe, Argentina, S2002KDS
    - Hospital Provincial del Centenario
Australia
- New South Wales
  - Camperdown, New South Wales, Australia, 2050
    - AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital
  - Kingswood, New South Wales, Australia, 2747
    - Department of Gastroenterology & Hepatology, Nepean Hospital
- Queensland
  - Brisbane, Queensland, Australia, 4120
    - Gallipoli Medical Research Foundation
- South Australia
  - Adelaide, South Australia, Australia, 5042
    - Flinders Medical Centre
  - Adelaide, South Australia, Australia, 5000
    - Department of Gastroenterology and Hepatology, Royal Adelaide Hospital
- Victoria
  - Box Hill, Victoria, Australia, 3128
    - Box Hill Hospital
  - Fitzroy, Victoria, Australia, 3065
    - St. Vincent's Hospital Melbourne
  - Heidelberg, Victoria, Australia, 3084
    - Austin Hospital
- Western Australia
  - Murdoch, Western Australia, Australia, 6150
    - Fiona Stanley Hospital, Gastroenterology Department
Austria
- - Vienna, Austria, 1090
    - AKH, Medical University of Vienna
Belgium
- - Bruxelles, Belgium, 1070
    - CUB Hôpital Erasme
  - Ghent, Belgium, 9000
    - University Hospital Ghent
- Antwerp
  - Edegem, Antwerp, Belgium, 2650
    - University Hospital Antwerp
- Vlaams-Brabant
  - Leuven, Vlaams-Brabant, Belgium, 3000
    - UZ Leuven
Brazil
- - Rio de Janeiro, Brazil, 20270-004
    - Universidade Federal do Estado do Rio de Janeiro - Hospital Universitario Gaffree e Guinle/HUGG/UNIRIO
  - Sao Paulo, Brazil, 05403-000
    - Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo-HCFMUSP
- Bahia
  - São Salvador, Bahia, Brazil, 41253-190
    - Hospital Sao Rafael
- Campinas
  - Sao Paulo, Campinas, Brazil, 13083-878
    - Gastrocentro/ Universidade Estadual de Campinas (UNICAMP)
- Distrito Federal Brazil
  - Brasilia, Distrito Federal Brazil, Brazil, 70335-900
    - Instituto Hospital de Base do Distrito Federal-IHBDF
- Goias
  - Goiânia, Goias, Brazil, 74535-170
    - Instituto Goiano de Gastroenterologia
- Maranhao
  - Sao Luis, Maranhao, Brazil, 65020-600
    - Cepec Huufma
- Minas Gerais
  - Belo Horizonte,, Minas Gerais, Brazil, 30130-100
    - Hospital das Clinicas da Universidade Federal de Minas Gerais (UFMG)
- Rio Grande Do Sul
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
    - Hospital de Clinicas de Porto Alegre
- Salvador
  - Bahia, Salvador, Brazil, 40110-060
    - Hospital Universitario Professor Edgard Santos
- Sao Paulo
  - Campinas, Sao Paulo, Brazil, 13083-878
    - Gastrocentro. Unidad Estadual de CAmpinas UNICAMP
Bulgaria
- - Sofia, Bulgaria, 1431
    - St. Ivan Rilsky University Hospital
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N-4Z6
    - University of Calgary Liver Unit (Heritage Medical Research Clinic)
  - Edmonton, Alberta, Canada, T6G 2X8
    - University of Alberta, Walter C. Mackenzie Health Sciences Centre (WMC)
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 3P6
    - University of Manitoba, Health Sciences Centre
- Ontario
  - London, Ontario, Canada, N6A 5A5
    - London Health Sciences Centre-University Hospital
  - Toronto, Ontario, Canada, M5G 2C4
    - University Health Network, Toronto General Hospital
- Quebec
  - Montreal, Quebec, Canada, H2X 3J4
    - CHUM
Chile
- V Región
  - Viña Del Mar, V Región, Chile, 2540488
    - Centro de Investigaciones Clinicas Vina del Mar
Denmark
- - København Ø, Denmark, 2100
    - Medicinsk klinik for mave, tarm-og leversygdomme
  - Odense, Denmark, 5000
    - Odense University Hospital Afdeling for medicinske mave-tarmsygdomme S
- Aarhus C
  - Aarhus, Aarhus C, Denmark, 8000
    - Aarhus University Hospital Department of Hepatology and Gastroenterology
Estonia
- - Tartu, Estonia, 51014
    - Tartu University Hospital
- Harju
  - Tallinn, Harju, Estonia, 10138
    - East Tallinn Central Hospital Gastroenterology Center
Finland
- - Helsinki, Finland, 00290
    - Helsinki University Central Hospital
  - Turku,, Finland, 20521
    - Turku University Central Hospital, Gastroenterology Outpatient Clinic
France
- - Lille, France, 59037
    - CHRU Hôpital HURIEZ
  - Pessac Cedex, France, 33604
    - CHU de Bordeaux - Hôpital Haut Leveque
- Paris
  - Paris Cedex 12, Paris, France, 75571
    - Hospital Saint-Antoine, A.P.-H.P.
Germany
- - Berlin, Germany, D-13353
    - CHARITÉ, Campus Virchow Klinikum
  - Hamburg, Germany, 20246
    - Univeritatsklinikum Hamburg Eppendorf, Medizinische Klinik und Poliklinik
  - Heidelberg, Germany, 69120
    - Universitaetsklinikum Heidelberg Medizinische Universitaetsklinik
  - Leipzig, Germany, 04103
    - Universität Leipzig KöR, Medizinische Fakultät
  - Munich, Germany, 81377
    - University of Munich, LMU Klinikum Grosshadern
- Hessen
  - Frankfurt am Main, Hessen, Germany, 60590
    - Klinikum der Johann-Wolfgang Goethe, Universitaet Frankfurt am Main
- Lower Saxony
  - Hannover, Lower Saxony, Germany, D-30625
    - Medizinische Hochschule Hannover, Klinik für Gastroenterologie, Hepatologie und Endokrinologie
- QLD
  - Erlangen, QLD, Germany, 91054
    - Friedrich-Alexander-Uniersitat Erlangen
Hong Kong
- - Hong Kong, Hong Kong
    - Alice Ho Miu Ling Nethersole Hospital
  - Hong Kong, Hong Kong
    - Humanity & Health Research Centre
- Pokfulam
  - Hong Kong, Pokfulam, Hong Kong
    - Queen Mary Hospital
- Shatin
  - Hong Kong, Shatin, Hong Kong
    - Prince of Wales Hospital
- Tuen Mun, New Territories
  - Hong Kong, Tuen Mun, New Territories, Hong Kong
    - Tuen Mun Hospital
Hungary
- - Bekescsaba, Hungary, H-5600
    - Békés Megyei Központi Kórház - dr. Réthy Pál Tagkórház
  - Budapest, Hungary, H-1125
    - Szent János Hospital
  - Debrecen, Hungary, 4032
    - University Of Debrecen, Department Of Medicine, Division Of Gastroenterology
Israel
- - Beer Sheva, Israel, 84104
    - Soroka Medical Center
  - Haifa, Israel, 31096
    - Rambam Health Care Campus
  - Jerusalem, Israel, 91031 02
    - Shaare Zedek Medical Center
  - Petach Tikva, Israel, 49100
    - Rabin Medical Center
  - Ramat-Gan, Israel, 52656 01
    - Sheba Medical Center
  - Tel-Aviv, Israel, 64239
    - Sourasky Tel-Aviv Medical Center
- Nazareth Elit
  - Jerusalem, Nazareth Elit, Israel, POB 12000, 91120
    - Hadassah Hebrew University Medical Center
Italy
- - Ancona, Italy, 71-60126
    - Università Politecnica delle Marche - Azienda Ospedaliero
  - Bologna, Italy, 40138
    - AOU Policlinico Sant' Orsola Malpighi
  - Bologna, Italy, 40138
    - Azienda Ospedaliero Universitaria Sant´ Orsola Malpighi
  - Florence, Italy, 50139
    - Azienda Ospedaliero Universitaria Careggi Universita di Firenze
  - Milano, Italy, 20142
    - Azienda Socio-Sanitarla Territoriale (ASST) Santi Paolo e Carlo
  - Modena, Italy, 41126
    - AOU Ospedale Civile S. Agostino Estense - UO Medicina Metabolica
  - Monza, Italy, 20900
    - Azienda Socio Sanitaria Territoriale (ASST) di Monza
  - Padova, Italy, 35128
    - Azienda Ospedaliero - Universita di Padova
  - Palermo, Italy, 90127
    - AOU Policlinico Paolo Giaccone - Di.Bi.M.I.S
  - Rome, Italy, 00168
    - Policlinico Universitario Agostino Gemelli - Universita Cattolica del Sacro Cuore
- Cagliari
  - Monserrato, Cagliari, Italy, 09042
    - Azienda Ospedaliero - Universitaria di Cagliari - Centro per lo Studio delle Malattie del Fegato
Korea, Republic of
- Busanjin-gu
  - Busan, Busanjin-gu, Korea, Republic of, 47392
    - Inje University Busan Paik Hospital
- Gangnam-gu
  - Seoul, Gangnam-gu, Korea, Republic of, 06273
    - Gangnam Severance Hospital
- Gyeonggi-do
  - Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
    - Seoul National University Bundang Hospital
- Jongno-Gu
  - Seoul, Jongno-Gu, Korea, Republic of, 03080
    - Seoul National University Hospital
- Seo-gu
  - Busan, Seo-gu, Korea, Republic of, 49241
    - Pusan National University Hospital
Lithuania
- - Kaunas, Lithuania, LT 50009
    - Hospital of Lithuanian University of Health Sciences, Kauno Klinikos
  - Vilnius, Lithuania, LT-08661
    - Vilnius University hospital Santaros klinikos
Mexico
- Ciudad De Mexico,
  - Ciudad de mexico, Ciudad De Mexico,, Mexico, 14050
    - Medica Sur, S.A.B. de C.V.
- DF
  - Mexico City, DF, Mexico, 14000
    - Departamento De Gastroenterologia. Instituto Nacional De Ciencias Medicas Y Nutricion Salvador Zubiran
  - Mexico City, DF, Mexico, 6700
    - Consultorio Médico de la Dra Alma Laura Ladrón de Guevara Cetina
Netherlands
- - Amsterdam, Netherlands, 1105 AZ
    - Amsterdam University Medical Centre (AMC)
  - Utrecht, Netherlands, 3584CX
    - University Medical Center Utrecht
- Gelderland
  - Nijmegen, Gelderland, Netherlands, 6525 GA
    - Radboud UMC
- Noord-Holland
  - Amsterdam, Noord-Holland, Netherlands, 1081HV
    - Vrije Universiteit Medisch Centrum (Vumc)
- Zuid Holland
  - Rotterdam, Zuid Holland, Netherlands, 3015 CE
    - Erasmus MC
New Zealand
- Auckland
  - Grafton, Auckland, New Zealand, 1023
    - NZ Liver Transplant Unit, Auckland Hospital
- Canterbury
  - Christchurch, Canterbury, New Zealand, 4710
    - Gastroenterology, Christchurch Hospital
Poland
- - Lublin, Poland, 20-094
    - Dep. Of Gastroenterology UM Lublin
- Kujawsko-Pomorskie
  - Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-078
    - NZOZ Vitamed
- Lover Silesia
  - Wroclaw, Lover Silesia, Poland, 51-149
    - Wojewodzki Szpital Specjalistyczny im. J. Gromkowskiego, Pierwszy Oddzial Chorob Zakaznych
- Masovia
  - Warsaw, Masovia, Poland, 02-097
    - Medical University of Warsaw Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie (SPCSK in Warsaw
- Mazovia
  - Warsaw, Mazovia, Poland, 02-781
    - Centrum Onkologii - Instytut im. Marii Skłodowskiej - Curie, Klinika Gastroenterologii Onkologicznej
- Silesia
  - Katowice, Silesia, Poland, 40-752
    - Oddział Gastr. I Hepat. Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibińskiego Sum
Portugal
- - Lisbon, Portugal, 1649-035
    - Centro Hospitalar Lisboa Norte, EPE - Hospital de Santa Maria
Serbia
- - Belgrade, Serbia, 11000
    - Clinical Hospital Centre Zvezdara
  - Belgrade, Serbia, 11000
    - Clinic For Gastroenterology And Hepatology Clinical Center Of Serbia
Spain
- - Barcelona, Spain, 08036
    - Hospital Clínic de Barcelona
  - Barcelona, Spain, 08035
    - Hospital Vall d'Hebron
  - Málaga, Spain, 29010
    - Virgen de la Victoria University Hospital
  - Sevilla, Spain, 41013
    - Hospital Universitario Virgen del Rocio
  - Valence, Spain, 46026
    - La Fe, Hospital ( Valence )
- Cantabria
  - Santander, Cantabria, Spain, 39008
    - Hospital Universitario Marqués de Valdecilla
- Madrid
  - Majadahonda, Madrid, Spain, 28222
    - Hospital Universitario Puerta de Hierro Majadahonda
Sweden
- - Gothenburg, Sweden, 413 45
    - Sahlgrenska Universitetssjukhuset
- Huddinge
  - Stockholm, Huddinge, Sweden, 14186
    - Karolinska University Hospital
Switzerland
- - Bern, Switzerland, 3010
    - Inselspital, University Of Bern, UVCM, DMLL
  - St. Gallen, Switzerland, 9007
    - Kantonsspital St. Gallen, Clinic for Gastroeterologie and Hepatologie
  - Zurich, Switzerland, 8091
    - USZ, Klinik für Gastroenterologie und Hepatologie
Turkey
- - Ankara, Turkey, 6100
    - Ankara University School of Medicine Gastroenterology Dept.
  - Izmir, Turkey, 35100
    - Ege University School of Medicine Gastroenterology Dept.
United Kingdom
- - Cambridge, United Kingdom, CB2 0QQ
    - Cambrigde University Hospitals NHS Foundation Trust
  - London, United Kingdom, NW3 2QG
    - The Royal Free Hospital
  - Nottingham, United Kingdom, NG7 2UH
    - Nottingham University Hospital NHS Trust
- Avon
  - Bristol, Avon, United Kingdom, BS2 8HW
    - University Hospitals Bristol NHS Foundation Trust
- Devon
  - Plymouth, Devon, United Kingdom, PL6 8DH
    - Plymouth Hospitals NHS Trust, Derriford Hospital
- Lanarkshire
  - Glasgow, Lanarkshire, United Kingdom, G12 0YN
    - Gartnavel General Hospital
- Scotland
  - Larbert, Scotland, United Kingdom, FK5 4WR
    - Forth Valley Royal Hospital
- Tyne And Wear
  - Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE2 4HH
    - Institute of Cellular Medicine
- West Midlands
  - Birmingham, West Midlands, United Kingdom, B15 2GW
    - University Hospitals Birmingham NHS Foundation Trust
United States
- Arizona
  - Phoenix, Arizona, United States, 85054
    - Mayo Clinic Arizona
- California
  - Los Angeles, California, United States, 90048
    - Cedars-Sinai Medical Center
  - Rialto, California, United States, 92377
    - Inland Empire Liver Foundation
  - Sacramento, California, United States, 95817
    - University of California Davis, Davis Medical Center
  - Stanford, California, United States, 94304
    - Stanford University
- Colorado
  - Aurora, Colorado, United States, 80045
    - University of Colorado Denver and Hospital
- Florida
  - Gainesville, Florida, United States, 32610
    - UF Hepatology Research at CTRB
  - Miami, Florida, United States, 33163
    - Schiff Center for Liver Diseases/University of Miami
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Emory University Hospital
  - Atlanta, Georgia, United States, 30309
    - Piedmont Atlanta Hospital
  - Marietta, Georgia, United States, 30060
    - Gastrointestinal Specialists of Georgia
- Illinois
  - Chicago, Illinois, United States, 60637
    - University of Chicago Medical Center
  - Chicago, Illinois, United States, 60637
    - Northwestern University Feinberg School of Medicine
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Indiana University
  - Indianapolis, Indiana, United States, 46237
    - Indianapolis Gastroenterology Research Foundation
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - University of Louisville, Medical Dental Complex
- Louisiana
  - New Orleans, Louisiana, United States, 70112
    - Tulane University Medical Center
- Maryland
  - Baltimore, Maryland, United States, 21202
    - Mercy Medical Center
- Massachusetts
  - Worcester, Massachusetts, United States, 01655
    - UMass Medical School
- Michigan
  - Novi, Michigan, United States, 48377
    - Henry Ford Health System
- Minnesota
  - Saint Paul, Minnesota, United States, 55114
    - Minnesota Gastroenterology, P.A.
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - Southern Therapy and Advanced Research (STAR)
- Missouri
  - Kansas City, Missouri, United States, 64131
    - Kansas City Research Institute
  - Saint Louis, Missouri, United States, 63104
    - Saint Louis University Gastroenterology & Hepatology
- New Jersey
  - Paterson, New Jersey, United States, 07503
    - Saint Joseph's Regional Medical Center
- New York
  - New York, New York, United States, 10021
    - Weill Cornell Medical College
  - New York, New York, United States, 10003
    - Mount Sinai Beth Israel
  - Rochester, New York, United States, 14642
    - University of Rochester Medical Center
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104
    - Hospital of the University of Pennsylvania
- Tennessee
  - Nashville, Tennessee, United States, 37211
    - Quality Medical Research, PLLC
- Texas
  - Dallas, Texas, United States, 75390
    - UT Southwestern Medical Center
  - Dallas, Texas, United States, 75246
    - Baylor University Medical Center
  - Dallas, Texas, United States, 75203
    - The Liver Institute At Methodist Dallas Medical Center
  - Dallas, Texas, United States, 75246
    - Texas Digestive Disease Consultants
  - Fort Sam Houston, Texas, United States, 78234
    - Brooke Army Medical Center
  - Fort Worth, Texas, United States, 76104
    - Baylor Scott and White Research Institute
  - Houston, Texas, United States, 77030
    - Baylor College of Medicine - Advanced Liver Therapies
  - Houston, Texas, United States, 77030
    - UT Health The University of Texas Health Science Center at Houston
  - San Antonio, Texas, United States, 78215
    - American Research Corporation at Texas Liver Institute
  - Southlake, Texas, United States, 76092
    - Texas Digestive Disease Consultants
- Utah
  - Murray, Utah, United States, 84123
    - Clinical Research Centers Of America
- Virginia
  - Richmond, Virginia, United States, 23249
    - McGuire DVAMC
- Washington
  - Seattle, Washington, United States, 98104
    - Swedish Organ Transplant & Liver Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

Definite or probable PBC diagnosis (consistent with American Association for the Study of Liver Diseases [AASLD] and the European Association for the Study of the Liver [EASL] practice guidelines; Lindor 2009; EASL 2009), as demonstrated by the presence of ≥2 of the following 3 diagnostic factors:
- History of elevated Alkaline phosphatase levels for at least 6 months
- Positive antimitochondrial antibody (AMA) titer or if AMA negative or in low titer (<1:80) PBC-specific antibodies (anti-GP210 and/or anti-SP100 and/or antibodies against the major M2 components [PDC-E2, 2-oxo-glutaric acid dehydrogenase complex])
- Liver biopsy consistent with PBC
A mean total bilirubin >ULN and ≤5x ULN and/or a mean ALP >3x ULN
Either is not taking UDCA (no UDCA dose in the past 3 months) or has been taking UDCA for at least 12 months with a stable dose for ≥3 months prior to Day 0

Exclusion Criteria:

History or presence of other concomitant liver diseases including:
- Hepatitis C virus infection
- Active Hepatitis B infection; however, subjects who have seroconverted (hepatitis B surface antigen and hepatitis B e antigen negative) may be included in this study after consultation with the medical monitor
- Primary sclerosing cholangitis (PSC)
- Alcoholic liver disease
- Definite autoimmune liver disease or overlap hepatitis
- Nonalcoholic steatohepatitis (NASH)
- Gilbert's Syndrome
Presence of clinical complications of PBC or clinically significant hepatic decompensation, including:
- History of liver transplant, current placement on a liver transplant list, or current Model of End Stage Liver Disease (MELD) score >12. Subjects who are placed on a transplant list despite a relatively early disease stage (for example per regional guidelines) may be eligible as long as they do not meet any of the other exclusion criteria
- Cirrhosis with complications, including history (within the past 12 months) or presence of:
  - Variceal bleed
  - Uncontrolled ascites
  - Encephalopathy
  - Spontaneous bacterial peritonitis
- Known or suspected HCC
- Prior transjugular intrahepatic portosystemic shunt procedure
- Hepatorenal syndrome (type I or II) or screening (Visit 1 or 2) serum creatinine >2 mg/dL (178 μmol/L)
Mean total bilirubin >5x ULN
Subjects who have undergone gastric bypass procedures (gastric lap band is acceptable) or ileal resection or plan to undergo either of these procedures
Other medical conditions that may diminish life expectancy, including known cancers (except carcinomas in situ or other stable, relatively benign conditions)
If female: plans to become pregnant, known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
Known history of human immunodeficiency virus infection
Medical conditions that may cause nonhepatic increases in ALP (eg, Paget's disease or fractures within 3 months)
Other clinically significant medical conditions that are not well controlled or for which medication needs are anticipated to change during the study
History of alcohol abuse or other substance abuse within 1 year prior to Day 0
Participation in another investigational product, biologic, or medical device study within 30 days prior to Screening. Participation in a previous study of OCA is allowed with 3 months washout prior to enrollment in this study
Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain
History of known or suspected clinically significant hypersensitivity to OCA or any of its components
UDCA naïve (unless contraindicated)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo One tablet daily (or a lower frequency depending on CP score) for the remainder of the study
Experimental: Obeticholic Acid (OCA) 5 mg to 10 mg Obeticholic Acid (OCA) 5 mg for a minimum 3 months and then titrating up to a maximum 10 mg for the remainder of the trial (based on tolerability and CP Score).	Drug: Obeticholic Acid (OCA) Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, subsequently titrating up to a maximum dose and frequency of 10 mg OCA twice weekly based on tolerability and biochemical response for the duration of the study. Other Names: INT-747 6alpha-ethylchenodeoxycholic acid (6-ECDCA)

Participant Group / Arm

Intervention / Treatment

Placebo Comparator: Placebo

Drug: Placebo

One tablet daily (or a lower frequency depending on CP score) for the remainder of the study

Experimental: Obeticholic Acid (OCA) 5 mg to 10 mg

Obeticholic Acid (OCA) 5 mg for a minimum 3 months and then titrating up to a maximum 10 mg for the remainder of the trial (based on tolerability and CP Score).

Drug: Obeticholic Acid (OCA)

Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants).

Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, subsequently titrating up to a maximum dose and frequency of 10 mg OCA twice weekly based on tolerability and biochemical response for the duration of the study.

Other Names:

INT-747
6alpha-ethylchenodeoxycholic acid (6-ECDCA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the First Occurrence of Composite Endpoint Time Frame: Time to first occurrence from date of randomization until the time to accrue approximately 127 primary endpoint events (up to 7 years)	To assess the effect of OCA, compared to placebo in conjunction with the established local standard of care, on clinical outcomes in participants with PBC as measured by time to the first occurrence of any of the following adjudicated events, derived as a composite event endpoint of death, liver transplant, model of end-stage liver disease (MELD) ≥15, uncontrolled ascites, or hospitalization for new onset or recurrence of variceal bleed, hepatic encephalopathy (as defined by a West Haven score of >=2), or spontaneous bacterial peritonitis. The clinical events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% confidence intervals (CIs) for the clinical events distribution percentiles (25th and 50th) are provided.	Time to first occurrence from date of randomization until the time to accrue approximately 127 primary endpoint events (up to 7 years)
Time to the First Occurrence of Primary Clinical Event (Expanded Endpoint) Time Frame: Time to first occurrence from date of randomization until the time to accrue approximately 127 primary endpoint events (up to 7 years)	Primary clinical outcome event is the first occurrence of the following events: death, liver transplant, MELD score >=15 (MELD-Na score >=12 baseline), MELD-Na score >=15 (MELD-Na score <12 baseline), hospitalization for new onset or recurrence of variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis), or bacterial empyema, uncontrolled or refractory ascites (requiring large volume paracentesis), portal hypertension syndromes, progression to decompensated liver disease, and progression to clinical evidence of portal hypertension without decompensation (for participants without decompensation or clinical evidence of portal hypertension at baseline). 71 endpoint events were observed in the OCA arm, and 80 were observed in the Placebo arm. The clinical events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% CIs for the clinical events distribution percentiles (25th and 50th) are provided.	Time to first occurrence from date of randomization until the time to accrue approximately 127 primary endpoint events (up to 7 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time To First Occurrence Of Severe Decompensating Events of Expanded Composite Endpoint Time Frame: Time to first occurrence from date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 7 years)	The first occurrence of the key secondary clinical event refers to the first occurrence of the following events: death, liver transplant, MELD-Na score >=15 if MELD-Na< 12 at baseline, MELD score >=15 if MELD-Na >=12 at baseline, uncontrolled or refractory ascites, portal hypertension syndromes (hepatorenal syndrome, portopulmonary syndrome, hepatopulmonary syndrome) or hospitalization for new onset or recurrence of variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis, or bacterial empyema. The clinical events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% CIs for the clinical events distribution percentiles (25th and 50th) are provided.	Time to first occurrence from date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 7 years)
Time To Liver Transplant Or Death (All-cause) Time Frame: Time to first occurrence from date of randomization until the date of first documented liver transplant or date of death from any cause (up to 7 years)	The effect of OCA compared to placebo on time to liver transplant or death (all-cause) was assessed. The events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% CIs for the clinical events distribution percentiles (25th and 50th) are provided.	Time to first occurrence from date of randomization until the date of first documented liver transplant or date of death from any cause (up to 7 years)
Time to First Occurrence of Fatal Event (All-Cause) Time Frame: Time to first occurrence from date of randomization until the date of death from any cause (up to 7 years)	The results represent the ratio of OCA to placebo. The fatal events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% CIs for the fatal events distribution percentiles (25th and 50th) are provided	Time to first occurrence from date of randomization until the date of death from any cause (up to 7 years)
Time to First Occurrence of Liver Transplant Time Frame: Time to first occurrence from date of randomization until the date of first documented liver transplant or date of death from any cause (up to 5 years)	The effect of OCA compared to placebo on time to occurrence of a liver transplant was assessed. The results represented the ratio of OCA to placebo. A hazard ratio <1 indicated an advantage for OCA. The event of interest was summarized through Cumulative Incidence Function (CIF) estimate at 5 years.	Time to first occurrence from date of randomization until the date of first documented liver transplant or date of death from any cause (up to 5 years)
Time to First Occurrence of Hospitalization Due to Hepatic Events Time Frame: Time to first occurrence from date of randomization until the date of hospitalization, liver transplant or death from any cause, whichever came first (up to 5 years)	Hospitalization events include new onset or recurrent variceal bleed, hepatic encephalopathy (as defined by a West Haven score of >=2), spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis OR presence of >250/mm^3 polymorph leucocytes [PMNs] in the ascitic fluid), bacterial empyema is confirmed by diagnostic thoracentesis OR presence of >250/mm^3 PMNs in the pleural fluid. The event of interest was summarized through CIF estimate at 5 years.	Time to first occurrence from date of randomization until the date of hospitalization, liver transplant or death from any cause, whichever came first (up to 5 years)
Time to First Occurrence of Uncontrolled or Refractory Ascites Time Frame: Time to first occurrence from date of randomization until the date of first documented uncontrolled or refractory ascites, liver transplant or date of death from any cause, whichever came first (up to 5 years)	Uncontrolled or refractory ascites are defined as diuretic-resistant ascites requiring large-volume paracentesis. The effect of OCA compared to placebo on time to the first occurrence of uncontrolled or refractory ascites was assessed. The event of interest was summarized through CIF estimate at 5 years.	Time to first occurrence from date of randomization until the date of first documented uncontrolled or refractory ascites, liver transplant or date of death from any cause, whichever came first (up to 5 years)
Time to First Occurrence of MELD Score ≥15 Time Frame: Time to first occurrence from date of randomization until the date of first documented MELD Score ≥15, liver transplant or date of death from any cause, whichever came first (up to 5 years)	The MELD score is useful in assessing participants with significant decompensation. The MELD score is now used by the United Network for Organ Sharing in the United States and Eurotransplants to manage organ allocation for liver transplantation. The MELD score is derived from the participant's serum total bilirubin, serum creatinine, and International Normalized Ratio (INR), as appropriate, to predict survival. The MELD score ranges from 6 to 40. The higher the score, the more likely a participant will receive a liver from a deceased donor when an organ becomes available. The event of interest was summarized through CIF estimate at 5 years.	Time to first occurrence from date of randomization until the date of first documented MELD Score ≥15, liver transplant or date of death from any cause, whichever came first (up to 5 years)
Time To Development Of Varix/Varices Time Frame: Time to first occurrence from date of randomization until the date of first documented development of varix/varices, liver transplant or death from any cause, whichever came first (up to 5 years)	The effect of OCA compared to placebo on time to development of varix/varices was assessed. The event of interest was summarized through CIF estimate at 5 years.	Time to first occurrence from date of randomization until the date of first documented development of varix/varices, liver transplant or death from any cause, whichever came first (up to 5 years)
Time To Liver-Related Death Time Frame: Time to first occurrence from date of randomization until the date of first liver-related or non-liver- related death, whichever came first (up to 5 years)	The effect of OCA compared to placebo on time to liver-related death was assessed. The event of interest was summarized through CIF estimate at 5 years.	Time to first occurrence from date of randomization until the date of first liver-related or non-liver- related death, whichever came first (up to 5 years)
Time To Liver-Related Death Or Liver Transplant Time Frame: Time to first occurrence from date of randomization until the date of liver transplant, liver-related death or non-liver-related death from any cause, whichever came first (up to 5 years)	The effect of OCA compared to placebo on time to liver-related death or liver transplant was assessed. The event of interest was summarized through CIF estimate at 5 years.	Time to first occurrence from date of randomization until the date of liver transplant, liver-related death or non-liver-related death from any cause, whichever came first (up to 5 years)
Time To Liver-Related Death, Liver Transplant, Or MELD Score ≥15 Time Frame: Time to first occurrence from date of randomization until the date of liver transplant, liver-related death, non-liver-related death from any cause or MELD Score ≥15, whichever came first (up to 5 years)	The effect of OCA compared to placebo on time to liver-related death, liver transplant, or MELD Score ≥15 was assessed. The MELD score is useful in assessing participants with significant decompensation. The MELD score is now used by the United Network for Organ Sharing in the United States and Eurotransplants to manage organ allocation for liver transplantation. The MELD score is derived from the participant's serum total bilirubin, serum creatinine, and INR, as appropriate, to predict survival. The MELD score ranges from 6 to 40. The higher the score, the more likely a participant will receive a liver from a deceased donor when an organ becomes available. The event of interest was summarized through CIF estimate at 5 years.	Time to first occurrence from date of randomization until the date of liver transplant, liver-related death, non-liver-related death from any cause or MELD Score ≥15, whichever came first (up to 5 years)
Progression To Cirrhosis (for Noncirrhotic Subjects at Baseline) Time Frame: Time to first occurrence from date of randomization until the date of cirrhosis, liver transplant or death from any cause, whichever came first (up to 5 years)	When a participant is identified as noncirrhotic at the Baseline and exhibited any signs or symptoms associated with progression to cirrhosis, the participant was assessed by Fibroscan® TE where available. The event of interest was summarized through CIF estimate at 5 years.	Time to first occurrence from date of randomization until the date of cirrhosis, liver transplant or death from any cause, whichever came first (up to 5 years)
Time To Occurrence Of Hepatocellular Carcinoma (HCC) Time Frame: Time to first occurrence from date of randomization until the date of HCC diagnosis, liver transplant or death from any cause, whichever came first (up to 5 years)	The effect of OCA compared to placebo on time to occurrence of HCC was assessed. The event of interest was summarized through CIF estimate at 5 years.	Time to first occurrence from date of randomization until the date of HCC diagnosis, liver transplant or death from any cause, whichever came first (up to 5 years)
Change From Baseline To Month 24 Of Total Bilirubin Time Frame: Baseline up to Month 24	Liver biochemistry, which includes total bilirubin, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using mixed model repeated measures (MMRM), including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.	Baseline up to Month 24
Change From Baseline To Month 24 Of Direct Bilirubin Time Frame: Baseline up to Month 24	Liver biochemistry, which includes direct bilirubin, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.	Baseline up to Month 24
Change From Baseline To Month 24 Of Aspartate Aminotransferase (AST) Time Frame: Baseline up to Month 24	Liver biochemistry, which includes AST, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.	Baseline up to Month 24
Change From Baseline To Month 24 Of Alanine Aminotransferase (ALT) Time Frame: Baseline up to Month 24	Liver biochemistry, which includes ALT, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.	Baseline up to Month 24
Change From Baseline To Month 24 Of Alkaline Phosphatase (ALP) Time Frame: Baseline up to Month 24	Liver biochemistry, which includes ALP, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.	Baseline up to Month 24
Change From Baseline To Month 24 Of Gamma-glutamyl Transferase (GGT) Time Frame: Baseline up to Month 24	Liver biochemistry, which includes GGT, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.	Baseline up to Month 24
Change From Baseline To Month 24 Of Albumin Time Frame: Baseline up to Month 24	Liver biochemistry, which includes albumin, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.	Baseline up to Month 24
Change From Baseline To Month 24 Of INR Time Frame: Baseline up to Month 24	The coagulation test, which includes INR, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. INR is the ratio of tested prothrombin time to normal prothrombin time, to a power designated the international sensitivity index (ISI). INR normal range is 0.8 to 1.2 (female and male). Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate.	Baseline up to Month 24
Change From Baseline To Month 72 Of MELD Score Time Frame: Baseline up to Month 72	The MELD score is useful in assessing participants with significant decompensation. The MELD score is now used by the United Network for Organ Sharing in the United States and Eurotransplants to manage organ allocation for liver transplantation. The MELD score is derived from the participant's serum total bilirubin, serum creatinine, and INR, as appropriate, to predict survival. The MELD score ranges from 6 to 40. The higher the score, the more likely a participant will receive a liver from a deceased donor when an organ becomes available.	Baseline up to Month 72
Change From Baseline To Month 72 Of MELD-Na Score Time Frame: Baseline up to Month 72	The MELD-Na score is another useful predictor in assessing participants with significant decompensation. The MELD-Na took into account the effect of serum sodium as a reflection of renal function and hypothetically may improve the accuracy of the model score. The MELD-Na score is derived from the participant's serum total bilirubin, serum creatinine, INR, and serum sodium, as appropriate, to predict survival. The MELD-Na score ranges from 6 to 40. The higher the score, the more likely a participant will receive a liver from a deceased donor when an organ becomes available.	Baseline up to Month 72
Change From Baseline To Month 72 Of CPS Time Frame: Baseline up to Month 72	Child-Pugh Score (Pugh 1973, Lucey 1997) was calculated and reported within the electronic data capture (EDC) system based on data entered into the CRF by adding the scores from the 5 factors and could have ranged from 5 to15. A total score of 5 to 6 was considered Grade A (mild, well-compensated disease); 7 to 9 was Grade B (moderate, significant functional compromise); and 10 and above was Grade C (severe, decompensated disease).	Baseline up to Month 72
Change From Baseline To Month 72 Of Mayo Risk Score (MRS) Time Frame: Baseline up to Month 72	Mayo Risk Score (MRS) was calculated and reported within the EDC system. Calculation of MRS included Investigator assessment of peripheral edema and the use of diuretic therapy, which was assessed during the adverse event and concomitant medicine review at the scheduled visits and entered into the CRF, as well as total bilirubin, albumin, and prothrombin time results obtained from the central laboratory data. There is no maximum and minimum range of score but an increase in the MRS represents an increase in the risk of death.	Baseline up to Month 72
Change From Baseline To Month 72 Of Immunoglobulin-M (IgM) Time Frame: Baseline up to Month 72	Markers of inflammation, which include IgM, were assessed.	Baseline up to Month 72
Change From Baseline To Month 72 Of C-reactive Protein (CRP) Time Frame: Baseline up to Month 72	Markers of inflammation, which include CRP, were assessed.	Baseline up to Month 72
Change From Baseline To Month 72 Of Tumor Necrosis Factor-α (TNF-α) Time Frame: Baseline up to Month 72	Markers of inflammation, which include TNF-α, were assessed.	Baseline up to Month 72
Change From Baseline To Month 72 Of Fibroblast Growth Factor-19 (FGF-19) Time Frame: Baseline up to Month 72	Markers of hepatic fibrosis, which include FGF-19, were assessed.	Baseline up to Month 72
Change From Baseline To Month 72 Of Cytokeratin-18 (CK-18) Time Frame: Baseline up to Month 72	Markers of inflammation, which include CK-18, were assessed.	Baseline up to Month 72
Change From Baseline To Month 72 Of 7α-hydroxy-4-cholesten-3-one (C4) Time Frame: Baseline up to Month 72	Markers of hepatic fibrosis, which include C4, were assessed.	Baseline up to Month 72
Change From Baseline To Month 72 Of Enhanced Liver Fibrosis (ELF) Time Frame: Baseline up to Month 72	Liver fibrosis was assessed using ELF test. The ELF test assessed: hyaluronic acid, procollagen3 N-terminal peptide, and a tissue inhibitor of metalloproteinase 1. The ELF test is a composite score: < 7.7: no to mild fibrosis; ≥ 7.7 - < 9.8: Moderate fibrosis; ≥ 9.8 - < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis. A negative change from Baseline suggests decreased fibrosis.	Baseline up to Month 72
Change From Baseline To Month 72 Of Liver Stiffness - Transient Elastography Time Frame: Baseline up to Month 72	Hepatic stiffness was measured using non-invasive transient Elastography with Fibroscan® TE device.	Baseline up to Month 72
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Time Frame: Baseline up to the last IP dose plus 30 days and prior to commercial OCA initiation date (up to 7 years)	An adverse event (AE) was defined as any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or procedure, whether or not considered related to the medicinal product or procedure, which occurred during the course of the clinical study. TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.	Baseline up to the last IP dose plus 30 days and prior to commercial OCA initiation date (up to 7 years)
Pharmacokinetic (PK) Population: Fasting Trough Concentrations Of OCA By Dose Regimen Time Frame: Months 3, 6, 9, 12, 24, 36, 48, and 60	The fasting trough PK concentrations of OCA of different dose regimens taken throughout the study are reported.	Months 3, 6, 9, 12, 24, 36, 48, and 60
PK Population: Serial Concentration of OCA By Dose Regimen Time Frame: Month 9	In Month 9, blood samples were collected at predose, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4h, 5 h, and 6 h and PK serial concentrations at different dose regimen are reported.	Month 9
PK Population: Area Under The Concentration-Time Curve (AUC) From 0 to 6 Hours Post-dose (AUC0-6h) Of Participants Who Received 5 mg QD OCA and With CP Score=Non-Cirrhotic (NC) Time Frame: Month 9	In Month 9, blood samples were collected at predose, 0.5h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4h, 5 h, and 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC.	Month 9
PK Population: AUC From 0 to 24 Hours Post-dose (AUC0-24h) Of Participants Who Received 5 mg QD OCA and With CP Score=NC Time Frame: Month 9	In Month 9, blood samples were collected at predose, 0.5h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4h, 5 h, and 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC.	Month 9
PK Population: Maximum Observed Concentration (Cmax) Of Participants Who Received 5mg QD OCA and With CP Score=NC Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC.	Month 9
PK Population: Time to Cmax (Tmax) Of Participants Who Received 5mg QD OCA and With CP Score=NC Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC.	Month 9
PK Population: Metabolite to Parent Ratio of AUC0-6h (MRAUC) Of Participants Who Received 5mg QD OCA and With CP Score=NC Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC.	Month 9
PK Population: Metabolite to Parent Ratio of Cmax (MRCmax) Of Participants Who Received 5mg QD OCA and With CP Score=NC Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC.	Month 9
PK Population: AUC0-6h Of Participants Who Received 5 mg QD OCA and With CP Score=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.	Month 9
PK Population: AUC0-24h Of Participants Who Received 5 mg QD OCA and With CP Score=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.	Month 9
PK Population: Cmax Of Participants Who Received 5mg QD OCA and With CP Score=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.	Month 9
PK Population: Tmax Of Participants Who Received 5mg QD OCA and With CP Score=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.	Month 9
PK Population: Concentration at 24 Hours Post-dose (Ctrough) Of Participants Who Received 5mg QD OCA and With CP Score=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.	Month 9
PK Population: MRAUC Of Participants Who Received 5mg QD OCA and With CP Score=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.	Month 9
PK Population: MRCmax Of Participants Who Received 5mg QD OCA and With CP Score=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A.	Month 9
PK Population: Ctrough Of Participants Who Received 5mg QD OCA and With CP Score=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=B.	Month 9
PK Population: AUC0-6h Of Participants Who Received 5 mg QOD OCA and With CP Score=NC Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC.	Month 9
PK Population: AUC0-24h Of Participants Who Received 5 mg QOD OCA and With CP Score=NC Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC	Month 9
PK Population: Cmax Of Participants Who Received 5mg QOD OCA and With CP Score=NC Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC.	Month 9
PK Population: Tmax Of Participants Who Received 5mg QOD OCA and With CP Score=NC Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC.	Month 9
PK Population: Ctrough Of Participants Who Received 5mg QOD OCA and With CP Score=NC Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC.	Month 9
PK Population: MRAUC Of Participants Who Received 5mg QOD OCA and With CP Score=NC Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC.	Month 9
PK Population: MRCmax Of Participants Who Received 5mg QOD OCA and With CP Score=NC Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC.	Month 9
PK Population: AUC0-6h Of Participants Who Received 10 mg QD OCA and With CP Score=NC Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.	Month 9
PK Population: AUC0-24h Of Participants Who Received 10 mg QD OCA and With CP Score=NC Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.	Month 9
PK Population: Cmax Of Participants Who Received 10 mg QD OCA and With CP Score=NC Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.	Month 9
PK Population: Tmax Of Participants Who Received 10 mg QD OCA and With CP Score=NC Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.	Month 9
PK Population: Ctrough Of Participants Who Received 10 mg QD OCA and With CP Score=NC Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.	Month 9
PK Population: MRAUC Of Participants Who Received 10 mg QD OCA and With CP Score=NC Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.	Month 9
PK Population: MRCmax Of Participants Who Received 10 mg QD OCA and With CP Score=NC Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC.	Month 9
PK Population: AUC0-6h Of Participants Who Received 10 mg QD OCA and With CP Score=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.	Month 9
PK Population: AUC0-24h Of Participants Who Received 10 mg QD OCA and With CPS Score=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.	Month 9
PK Population: Cmax Of Participants Who Received 10 mg QD OCA and With CP Score=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.	Month 9
PK Population: Tmax Of Participants Who Received 10 mg QD OCA and With CPS Score=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.	Month 9
PK Population: Ctrough Of Participants Who Received 10 mg QD OCA and With CP Score=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.	Month 9
PK Population: MRAUC Of Participants Who Received 10 mg QD OCA and With CP Score=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.	Month 9
PK Population: MRCmax Of Participants Who Received 10 mg QD OCA and With CP Score=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A.	Month 9
PK Population: AUC0-6h Of Participants Who Received 10 mg Q2W OCA and With CP Score=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B.	Month 9
PK Population: AUC0-24h Of Participants Who Received 10 mg Q2W OCA and With CP Score=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B.	Month 9
PK Population: Cmax Of Participants Who Received 10 mg Q2W OCA and With CP Score=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B.	Month 9
PK Population: Tmax Of Participants Who Received 10 mg Q2W OCA and With CP Score=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B.	Month 9
PK Population: Ctrough Of Participants Who Received 10 mg Q2W OCA and With CP Score=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B.	Month 9
PK Population: MRAUC Of Participants Who Received 10 mg Q2W OCA and With CP Score=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B	Month 9
PK Population: MRCmax Of Participants Who Received 10 mg Q2W OCA and With CP Score=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B.	Month 9
PK Population: AUC0-6h Of Participants Who Received 5 mg QD OCA and With MELD Category=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.	Month 9
PK Population: AUC0-24h Of Participants Who Received 5 mg QD OCA and With MELD Category=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.	Month 9
PK Population: Cmax Of Participants Who Received 5 mg QD OCA and With MELD Category=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.	Month 9
PK Population: Tmax Of Participants Who Received 5 mg QD OCA and With MELD Category=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.	Month 9
PK Population: Ctrough Of Participants Who Received 5 mg QD OCA and With MELD Category=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.	Month 9
PK Population: MRAUC Of Participants Who Received 5 mg QD OCA and With MELD Category=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.	Month 9
PK Population: MRCmax Of Participants Who Received 5 mg QD OCA and With MELD Category=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A.	Month 9
PK Population: AUC0-6h Of Participants Who Received 5 mg QD OCA and With MELD Category=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.	Month 9
PK Population: AUC0-24h Of Participants Who Received 5 mg QD OCA and With MELD Category=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.	Month 9
PK Population: Cmax Of Participants Who Received 5 mg QD OCA and With MELD Category=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.	Month 9
PK Population: Tmax Of Participants Who Received 5 mg QD OCA and With MELD Category=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.	Month 9
PK Population: Ctrough Of Participants Who Received 5 mg QD OCA and With MELD Category=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.	Month 9
PK Population: MRAUC Of Participants Who Received 5 mg QD OCA and With MELD Category=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.	Month 9
PK Population: MRCmax Of Participants Who Received 5 mg QD OCA and With MELD Category=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B.	Month 9
PK Population: AUC0-6h Of Participants Who Received 5 mg QOD OCA and With MELD Category=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.	Month 9
PK Population: AUC0-24h Of Participants Who Received 5 mg QOD OCA and With MELD Category=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.	Month 9
PK Population: Cmax Of Participants Who Received 5 mg QOD OCA and With MELD Category=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.	Month 9
PK Population: Tmax Of Participants Who Received 5 mg QOD OCA and With MELD Category=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.	Month 9
PK Population: Ctrough Of Participants Who Received 5 mg QOD OCA and With MELD Category=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.	Month 9
PK Population: MRAUC Of Participants Who Received 5 mg QOD OCA and With MELD Category=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.	Month 9
PK Population: MRCmax Of Participants Who Received 5 mg QOD OCA and With MELD Category=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A.	Month 9
PK Population: AUC0-6h Of Participants Who Received 10 mg QD OCA and With MELD Category=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A.	Month 9
PK Population: AUC0-24h Of Participants Who Received 10 mg QD OCA and With MELD Category=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A.	Month 9
PK Population: Cmax Of Participants Who Received 10 mg QD OCA and With MELD Category=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A	Month 9
PK Population: Tmax Of Participants Who Received 10 mg QD OCA and With MELD Category=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A.	Month 9
PK Population: Ctrough Of Participants Who Received 10 mg QD OCA and With MELD Category=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A.	Month 9
PK Population: MRAUC Of Participants Who Received 10 mg QD OCA and With MELD Category=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A.	Month 9
PK Population: MRCmax Of Participants Who Received 10 mg QD OCA and With MELD Category=A Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A.	Month 9
PK Population: AUC0-6h Of Participants Who Received 10 mg QD OCA and With MELD Category=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.	Month 9
PK Population: AUC0-24h Of Participants Who Received 10 mg QD OCA and With MELD Category=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.	Month 9
PK Population: Cmax Of Participants Who Received 10 mg QD OCA and With MELD Category=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.	Month 9
PK Population: Tmax Of Participants Who Received 10 mg QD OCA and With MELD Category=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.	Month 9
PK Population: Ctrough Of Participants Who Received 10 mg QD OCA and With MELD Category=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.	Month 9
PK Population: MRAUC Of Participants Who Received 10 mg QD OCA and With MELD Category=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.	Month 9
PK Population: MRCmax Of Participants Who Received 10 mg QD OCA and With MELD Category=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B.	Month 9
PK Population: AUC0-6h Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.	Month 9
PK Population: AUC0-24h Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.	Month 9
PK Population: Cmax Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.	Month 9
PK Population: Tmax Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.	Month 9
PK Population: Ctrough Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.	Month 9
PK Population: MRAUC Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.	Month 9
PK Population: MRCmax Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B Time Frame: Month 9	In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B.	Month 9
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 5 mg QD OCA Time Frame: Months 3, 6, 12, 24, and 48	The trough concentration of OCA in the cirrhotic participants who received 5 mg QD OCA was reported.	Months 3, 6, 12, 24, and 48
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 5 mg QD OCA Time Frame: Months 3, 6, 9, 12, and 24	The trough concentration of OCA in the non-cirrhotic participants who received 5 mg QD OCA was reported.	Months 3, 6, 9, 12, and 24
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 5 mg QOD OCA Time Frame: Months 6, 12, and 24	The trough concentration of OCA in the cirrhotic participants who received 5 mg QOD OCA was reported.	Months 6, 12, and 24
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 5 mg QOD OCA Time Frame: Months 3, 6, and 12	The trough concentration of OCA in the non-cirrhotic participants who received 5 mg QOD OCA was reported.	Months 3, 6, and 12
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 5 mg QW OCA Time Frame: Months 6 and 12	The trough concentration of OCA in the cirrhotic participants who received 5 mg QW OCA was reported.	Months 6 and 12
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 5 mg QW OCA Time Frame: Month 12	In Month 12, the trough concentration of OCA in the non-cirrhotic participants who received 5 QW QOD OCA was reported.	Month 12
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 5 mg Q2W OCA Time Frame: Months 6, 24, 36 and 48	The trough concentration of OCA in the cirrhotic participants who received 5 mg Q2W OCA was reported.	Months 6, 24, 36 and 48
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 5 mg Q2W OCA Time Frame: Months 3, 6, 12, 24, 36, and 48	The trough concentration of OCA in the non-cirrhotic participants who received 5 Q2W QOD OCA was reported.	Months 3, 6, 12, 24, 36, and 48
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 10 mg QD OCA Time Frame: Months 6, 9, 12, 24, 36, and 60	The trough concentration of OCA in the cirrhotic participants who received 10 mg QD OCA was reported.	Months 6, 9, 12, 24, 36, and 60
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 10 mg QD OCA Time Frame: Months 6, 9, 12, 24, and 36	The trough concentration of OCA in the non-cirrhotic participants who received 10 QD QOD OCA was reported.	Months 6, 9, 12, 24, and 36
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 10 mg QOD OCA Time Frame: Months 3, 6, 9, 12, 24, 36, 48, and 60		Months 3, 6, 9, 12, 24, 36, 48, and 60
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 10 mg QOD OCA Time Frame: Month 12	In Month 12, the trough concentration of OCA in the non-cirrhotic participants who received 10 mg QOD OCA was reported.	Month 12
PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 10 mg Q2W OCA Time Frame: Month 6	In Month 6, the trough concentration of OCA in the cirrhotic participants who received 10 mg Q2W OCA was reported.	Month 6
PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 10 mg Q2W OCA Time Frame: Month 6	In Month 6, the trough concentration of OCA in the non-cirrhotic participants who received 10 mg Q2W OCA was reported.	Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intercept Pharmaceuticals

Investigators

Study Director: Erik Ness, MD, Intercept Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 26, 2014

Primary Completion (Actual)

December 23, 2021

Study Completion (Actual)

December 23, 2021

Study Registration Dates

First Submitted

November 10, 2014

First Submitted That Met QC Criteria

December 2, 2014

First Posted (Estimate)

December 4, 2014

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

747-302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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General Publications

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Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

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Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Liver Cirrhosis, Biliary

Clinical Trials on Obeticholic Acid (OCA)

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