Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

Sponsoren

Hauptsponsor: Intercept Pharmaceuticals

Quelle Intercept Pharmaceuticals
Kurze Zusammenfassung

The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.

Gesamtstatus Active, not recruiting
Anfangsdatum August 30, 2017
Fertigstellungstermin June 2022
Primäres Abschlussdatum June 2021
Phase Phase 3
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Percentage of subjects with improvement in fibrosis by at least 1 stage with no worsening of NASH, using NASH Clinical Research Network (CRN) scoring system 18 months
Sekundäres Ergebnis
Messen Zeitfenster
Percentage of subjects with improvement in fibrosis by at least 2 stages, using Ishak scoring criteria 18 months
Percentage of subjects with NASH resolution, using the NASH CRN scoring 18 months
Einschreibung 919
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: Obeticholic acid (10 mg)

Beschreibung: Tablets administered orally once daily.

Armgruppenetikett: Obeticholic Acid (OCA) 10 mg

Interventionsart: Drug

Interventionsname: Obeticholic acid (10 mg to 25 mg)

Beschreibung: Tablets administered orally once daily.

Armgruppenetikett: Obeticholic Acid (OCA) 10 mg to 25 mg

Interventionsart: Drug

Interventionsname: Placebo

Beschreibung: Tablets administered orally once daily.

Armgruppenetikett: Placebo

Teilnahmeberechtigung

Kriterien:

Key inclusion criteria:

1. Subjects with a confirmed diagnosis of NASH and a fibrosis score of 4 based upon the NASH CRN scoring system determined by central reading

Key exclusion criteria:

1. Current or past history of a clinically evident hepatic decompensation event, such as ascites, hepatic encephalopathy (HE), or variceal bleeding

2. Current or past history of CP score ≥7 points

3. Model for End-stage Liver Disease (MELD) score > 12

4. ALT ≥ 5 X ULN

5. Calculated creatinine clearance <60mL/min using Cockcroft-Gault method

6. Hemoglobin A1c (HbA1c) ≥ 9.5 %

7. Evidence of other known forms of chronic liver disease such as alcoholic liver disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC)

8. History of liver transplant, or current placement on a liver transplant list

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Christian Weyer, MD Study Director Intercept Pharmaceuticals
Ort
Einrichtung:
University of Alabama at Birmingham Hospital | Birmingham, Alabama, 35294, United States
Digestive Health Specialists of the Southeast | Dothan, Alabama, 36305, United States
Objective GI d/b/a North Alabama GI Research Center | Madison, Alabama, 35758, United States
Arizona Liver Health | Chandler, Arizona, 85224, United States
Arizona Liver Health | Glendale, Arizona, 85306, United States
Arizona Liver Health | Tucson, Arizona, 85711, United States
Liver Wellness Center | Little Rock, Arkansas, 72205, United States
Arkansas Gastroenterology | North Little Rock, Arkansas, 72117, United States
Hope Clinical Research | Canoga Park, California, 91303, United States
Precision Research Institute | Chula Vista, California, 91910, United States
University of California, San Francisco-Fresno | Fresno, California, 93701, United States
Scripps Whittier Diabetes Institute | La Jolla, California, 92037, United States
eStudySite | La Mesa, California, 91942, United States
Keck Hospital of USC | Los Angeles, California, 90033, United States
Cedars-Sinani Medical Center | Los Angeles, California, 90048, United States
Palmtree Clinical Research, INC. | Palm Springs, California, 92262, United States
Stanford University Medical Center | Palo Alto, California, 94304, United States
California Liver Research Institute | Pasadena, California, 91105, United States
Alliance Clinical Research | Poway, California, 92064, United States
Inland Empire Liver Foundation | Rialto, California, 92377, United States
University of California, Davis Medical Center | Sacramento, California, 95817, United States
Kaiser Permanente Sacramento Medical Center | Sacramento, California, 95825, United States
University of California, San Francisco | San Francisco, California, 94143, United States
University of Colorado Denver and Hospital | Aurora, Colorado, 80045, United States
Peak Gastroenterology Associates | Colorado Springs, Colorado, 80907, United States
South Denver Gastroenterology, PC | Englewood, Colorado, 80113, United States
Innovative Medical Research of South Florida, Inc. | Aventura, Florida, 33180, United States
Medycal Research, Inc. | Brooksville, Florida, 34613, United States
Hi Tech and Global Research LLC | Coral Gables, Florida, 33134, United States
Top Medical Research, Inc. | Cutler Bay, Florida, 33189, United States
Integrity Clinical Research, LLC | Doral, Florida, 33166, United States
Nature Coast Clinical Research | Inverness, Florida, 34452, United States
UF Health Jacksonville-Gastroenterology Emerson | Jacksonville, Florida, 32207, United States
Mayo Clinic Florida | Jacksonville, Florida, 32224, United States
Schiff Center for Liver Diseases/University of Miami | Miami, Florida, 33136, United States
Sensible Healthcare, LLC | Ocoee, Florida, 34761, United States
Innovation Medical Research Center | Palmetto Bay, Florida, 33157, United States
Gastroenterology Associates of Pensacola, PA | Pensacola, Florida, 32503, United States
Tampa General Medical Group | Tampa, Florida, 33606, United States
Guardian Angel Research Center, INC | Tampa, Florida, 33614, United States
Florida Medical Clinic, P.A | Zephyrhills, Florida, 33542, United States
Summit Clinical Research, LLC | Athens, Georgia, 30607, United States
The Emory Clinic (TEC) | Atlanta, Georgia, 30322, United States
Gastrointestinal Specialists of Georgia | Marietta, Georgia, 30060, United States
Grand Teton Research Group, PLLC | Idaho Falls, Idaho, 83404, United States
Northwestern Medicine | Chicago, Illinois, 60611, United States
Rush University Medical Center | Chicago, Illinois, 60612, United States
Loyola University Medical Center | Maywood, Illinois, 60153, United States
Aquiant Research | New Albany, Indiana, 47150, United States
University of Iowa Hospitals and Clinics | Iowa City, Iowa, 52242, United States
Kansas City VA Medical Center | Kansas City, Kansas, 64128, United States
University of Kansas Medical Center | Kansas City, Kansas, 66160, United States
Kansas Medical Clinic | Topeka, Kansas, 66606, United States
University of Louisville, Clinical Trials Unit | Louisville, Kentucky, 40202, United States
Tandem Clinical Research, LLC | Marrero, Louisiana, 70072, United States
Delta Research Partners, LLC | Monroe, Louisiana, 71201, United States
Tulane University Health Sciences Center | New Orleans, Louisiana, 70112, United States
Louisiana Research Center | Shreveport, Louisiana, 71105, United States
University of Maryland, Institute of Human Virology | Baltimore, Maryland, 21201, United States
Mercy Medical Center | Baltimore, Maryland, 21202, United States
Walter Reed National Military Medical Center | Bethesda, Maryland, 20889, United States
Massachusetts General Hospital | Boston, Massachusetts, 02114, United States
Lahey Hospital & Medical Center | Burlington, Massachusetts, 01805, United States
UMass Memorial Health Care | Worcester, Massachusetts, 01655, United States
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center | Wyoming, Michigan, 49519, United States
Huron Gastroenterology Associates | Ypsilanti, Michigan, 48197, United States
Minnesota Gastroenterology, P.A. | Saint Paul, Minnesota, 55114, United States
Gulfport Memorial Hospital - Gen1 Research | Gulfport, Mississippi, 39501, United States
Southern Therapy and Advanced Research (STAR) LLC | Jackson, Mississippi, 39216, United States
University of Mississippi Medical Center | Jackson, Mississippi, 39216, United States
Kansas City Research Institute | Kansas City, Missouri, 64131, United States
Washington University School of Medicine | Saint Louis, Missouri, 63110, United States
CHI Health Alegent Creighton Clinic | Omaha, Nebraska, 68124, United States
Sierra Clinical Research | Las Vegas, Nevada, 89102, United States
Amici GI-LLC | Martinsville, New Jersey, 08836, United States
Rutgers New Jersey Medical School | Newark, New Jersey, 07103, United States
CHEAR Center LLC | Bronx, New York, 10455, United States
Montefiore Medical Center | Bronx, New York, 10467, United States
University at Buffalo, Clinical and Translational Research Center | Buffalo, New York, 14203, United States
Ichan School of Medicine at Mount Sinai Beth Israel | New York, New York, 10003, United States
NYU Langone Health | New York, New York, 10016, United States
Ichan School of Medicine at Mount Sinai | New York, New York, 10029, United States
Weill Cornell Medical College | New York, New York, 11735, United States
University of Rochester Medical Center | Rochester, New York, 14642, United States
Asheville Gastroenterology Associates, P.A. | Asheville, North Carolina, 28801, United States
University of North Carolina at Chapel Hill, School of Medicine | Chapel Hill, North Carolina, 27599, United States
Charlotte Gastroenterology & Hepatology, PLLC | Charlotte, North Carolina, 28207, United States
Duke University Medical Center | Durham, North Carolina, 27710, United States
Carolinas Center for Liver Disease/Carolinas HealthCare System | Huntersville, North Carolina, 28078, United States
Carolinas Health Care System Center for Liver Disease | Huntersville, North Carolina, 28078, United States
Diabetes & Endocrinology Consultants, PC | Morehead City, North Carolina, 28557, United States
PMG Research of Rocky Mount, LLC | Rocky Mount, North Carolina, 27804, United States
Trial Management Associates, LLC | Wilmington, North Carolina, 28403, United States
Dayton Gastroenterology, Inc. | Beavercreek, Ohio, 45440, United States
The Ohio State University Wexner Medical Center | Columbus, Ohio, 43210, United States
Northeast Clinical Research Center, LLC | Bethlehem, Pennsylvania, 18017, United States
Hillmont GI, pc | Flourtown, Pennsylvania, 19031, United States
The Pennsylvania State University and the Milton S. Hershey Medical Center | Hershey, Pennsylvania, 17033, United States
Thomas Jefferson University | Philadelphia, Pennsylvania, 19107, United States
Einstein Healthcare Network | Philadelphia, Pennsylvania, 19141, United States
UPMC - Center for Liver Diseases at the Thomas E. Starzl Institute | Pittsburgh, Pennsylvania, 15213, United States
University Gastroenterology | Providence, Rhode Island, 02905, United States
Ralph H. Johnson Veterans Affairs Medical Center | Charleston, South Carolina, 29401, United States
SCTR Research Nexus | Charleston, South Carolina, 29425, United States
Rapid City Medical Center LLP | Rapid City, South Dakota, 57701, United States
Gastro One | Germantown, Tennessee, 38138, United States
Associates in Gastroenterology, PLC | Hermitage, Tennessee, 37076, United States
Johnson City Medical Center | Johnson City, Tennessee, 37604, United States
Associates in Gastroenterology, PLC | Lebanon, Tennessee, 37090, United States
Methodist Healthcare University Hospital | Memphis, Tennessee, 38104, United States
Quaility Medical Research, PLLC | Nashville, Tennessee, 37211, United States
Vanderbilt University Medical Center - Digestive Disease Center | Nashville, Tennessee, 37232, United States
Texas Clinical Research Institute LLC | Arlington, Texas, 76012, United States
The Liver Institute at Methodist Dallas Medical Center | Dallas, Texas, 75203, United States
Liver Center of Texas | Dallas, Texas, 75234, United States
Texas Digestive Disease Consultants | Dallas, Texas, 75246, United States
UT Southwestern Medical Center | Dallas, Texas, 75390, United States
San Antonio Military Medical Center | Fort Sam Houston, Texas, 78234, United States
Baylor Scott and White All Saints Medical Center | Fort Worth, Texas, 76104, United States
Texas Digestive Disease Consultants | Fort Worth, Texas, 76104, United States
Baylor College of Medicine - Advanced Liver Therapies | Houston, Texas, 77030, United States
Baylor College of Medicine - Ben Taub Hospital | Houston, Texas, 77030, United States
The University of Texas Medical School at Houston | Houston, Texas, 77030, United States
Centex Studies, Inc. | Houston, Texas, 77058, United States
Centex Studies, Inc. | McAllen, Texas, 78504, United States
American Research Corporation | San Antonio, Texas, 78215, United States
Clinical Trials of Texas, Inc. | San Antonio, Texas, 78229, United States
Texas Digestive Disease Consultants | San Marcos, Texas, 78666, United States
The University of Vermont Medical Center | Burlington, Vermont, 05401, United States
Maryview Hospital, Inc. d/b/a Bon Secours Liver Institute of Hampton Roads | Newport News, Virginia, 23602, United States
Digestive and Liver Disease Specialists | Norfolk, Virginia, 23502, United States
Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours | Richmond, Virginia, 23226, United States
McGuire VA Medical Center | Richmond, Virginia, 23249, United States
Virginia Commonwealth University | Richmond, Virginia, 23298, United States
Gastroenterology Consultants of Southwest Virginia | Roanoke, Virginia, 24014, United States
Virginia Mason - Seattle Medical Center | Seattle, Washington, 98101, United States
Harborview Medical Center | Seattle, Washington, 98104, United States
Swedish Organ Transplant and Liver Center | Seattle, Washington, 98104, United States
University of Washington Medical Center | Seattle, Washington, 98195, United States
Nepean Blue Mountains Local Health District, Nepean Hospital | Kingswood, New South Wales, 2747, Australia
Gallipoli Medical Research Foundation | Greenslopes, Queensland, 4120, Australia
Mater Misericordiae Limited | South Brisbane, Queensland, 4101, Australia
Royal Adelaide Hospital | Adelaide, South Australia, 5000, Australia
Flinders Medical Centre | Bedford Park, South Australia, 5042, Australia
St Vincent's Hospital | Fitzroy, Victoria, 3065, Australia
Austin Health | Heidelberg, Victoria, 3084, Australia
Royal Melbourne Hospital | Parkville, Victoria, 3050, Australia
Fiona Stanley Hospital | Murdoch, Western Australia, 6150, Australia
University of Calgary Liver Unit (Heritage Medical Research Clinic) | Calgary, Alberta, T2M 4Z6, Canada
South Edmenton Gastroenterology | Edmonton, Alberta, T6L 6K3, Canada
Gordon and Leslie Diamond Helath Care Centre | Vancouver, British Columbia, V5Z 1M9, Canada
(G.I.R.I.) GI Research Institute | Vancouver, British Columbia, V6Z 2K5, Canada
Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority | Halifax, Nova Scotia, B3H 2Y9, Canada
Kent Place | Lindsay, Ontario, K9V 5G6, Canada
London Health Sciences Centre-University Hospital | London, Ontario, N6A 5A5, Canada
Office of Dr. Gauthier | North Bay, Ontario, PIB 2H3, Canada
Toronto Liver Centre | Toronto, Ontario, V5Z 1H2, Canada
Chronic Viral Illness/McGill University Health Centre (MUHC) | Montreal, Quebec, H4A 3JI, Canada
Clinique de medecine Urbaine du Quartier Latin | Montréal, Quebec, H2L 4E9, Canada
CHU Amiens Picardie | Amiens, 80054, France
Centre Hospitalier Universitaire d'Angers | Angers, 49933, France
Hôpital Beaujon- Service d'Hepatologie | Clichy, 92110, France
Center Hospitalier Universitaire Grenoble Alpes | La Tronche, 38700, France
Hôpital de la Croix Rousse | Lyon Cedex 04, 69317, France
CHU de Nice, Hôpital de l'Archet 2 | Nice, 06202, France
Hôpital Saint Antoine | Paris, 75012, France
Hôpital Pitié-Salpêtrierè | Paris, 75651, France
CHU de Bordeaux - GH Sud - Hôpital Haut-Lévêque | Pessac, 33604, France
CHU de Rouen-Centre Hospitalier Universitaire | Rouen, 76031, France
Centre Hospitalier Universitaire de Strasbourg | Strasbourg, 67000, France
Hôpital Hautepierre | Strasbourg, 67200, France
Hôpital Purpan | Toulouse, 31059, France
CHRU de Nancy - Hôpitaux de Brabois | Vandoeuvre-les-Nancy, 54511, France
Hôpital Paul Brousse | Villejuif, 94800, France
Univeritätsklinkum Ulm | Ulm, Baden Württemberg, 89081, Germany
Univeritätsklinkum Würzburg | Würzburg, Bayern, 97080, Germany
Teuber Consulting & Research UG | Frankfurt am main, Hessen, 60594, Germany
Katholische Kliniken Ruhrhalbinsel gGmbh | Essen, Nordrhein-Westfalen, 45257, Germany
Universitätsmedizin Mainz | Mainz, Rheinland-Pfalz, 55131, Germany
EUGASTRO GmbH | Leipzig, Sachsen, 04103, Germany
Universitätsklinikum Leipzig AöR | Leipzig, Sachsen, 04103, Germany
Gastroenterologisch-Hepatologisches Zentrum Kiel | Kiel, Schleswig-Holstein, 24146, Germany
Charité - Universitätsmedzin Berlin | Berlin, 13353, Germany
Universitätsklinikum Hamburg Eppendorf | Hamburg, 20246, Germany
Univeritätsmedizin Mannheim | Mannheim, 68167, Germany
Synexus Magyarország Kft. Budapest | Budapest, 1036, Hungary
Synexus Magyarorszag Kft. Debrecen A.S. | Debrecen, 4025, Hungary
Synexus Magyarorszag Kft. Gyula DRS | Gyula, 5700, Hungary
Middlemore Hospital | Auckland, 2025, New Zealand
Christchurch Hospital | Christchurch, 8011, New Zealand
Dunedin Public Hospital | Dunedin, 6021, New Zealand
Waikato Hospital | Hamilton, 3240, New Zealand
Wellington Regional Hospital | Wellington, 6021, New Zealand
Synexus Polska Sp. z o.o., Oddział w Częstochowie | Częstochowa, 42-200, Poland
Synexus Polska Sp. z.o.o., Oddział w Gdańsku | Gdańsk, 80-382, Poland
Synexus Polska Sp. Z.o.o., Oddział w Gdyni | Gdynia, 81-537, Poland
Synexus Polska Sp. z o.o., Oddział w Katowicach | Katowice, 40-040, Poland
Synexus Polska Sp. z o.o., Oddział w Poznaniu | Poznań, 60-702, Poland
Synexus Polska Sp. z o.o., Oddział w Wrocławiu | Wrocław, 50-381, Poland
Synexus Polska Sp. z o.o., Oddział w Łodzi | Łódź, 90-127, Poland
Latin Clinical Trial Center | San Juan, 00909, Puerto Rico
Fundación de Investigación de Diego | San Juan, 00927, Puerto Rico
Hospital Universitari Vall d'Hebron | Barcelona, 08035, Spain
Hospital Clínic de Barcelona | Barcelona, 08036, Spain
Hospital Universitario Ramon y Cajal | Madrid, 28034, Spain
Hospital Universitario La Paz | Madrid, 28046, Spain
Hospital Universitario Puerta de Hierro Majadahonda | Madrid, 28222, Spain
Hospital Universitario Marqués de Valdecilla | Santander, 39008, Spain
Hospital Universitario Virgen del Rocio | Sevilla, 41013, Spain
Hospital Clinico Universitario de Valencia | Valencia, 46010, Spain
Hospital General Universitario de Valencia | Valencia, 46014, Spain
Hospital Universitari i Politécnic La Fe | Valencia, 46026, Spain
Medical Center of LLC Medbud-Clinic, Clinical Diagnostic Department | Kyiv, 03037, Ukraine
Kyiv Railway Clinical Hospital №2 of branch "Health Center" of the Joint-Stock Company "Ukranian Railway", Day treatment department | Kyiv, 03049, Ukraine
Derby Teaching Hospitals NHS Foundation Trust | Derby, Derbyshire, DE22 3NE, United Kingdom
University Hospitals Birmingham NHS Foundation Trust | Birmingham, England, B15 2TH, United Kingdom
Addenbrooke's Hospital | Cambridge, England, CB2 0QQ, United Kingdom
Royal Free Hospital NHS Foundation Trust | London, England, NW3 2QG, United Kingdom
King's College Hospital NHS Foundation Trust | London, England, SE5 9RS, United Kingdom
Imperial College Healthcare NHS Trust, St Mary's Hospital | London, England, W2 INY, United Kingdom
Nottingham University Hospitals NHS Trust | Nottingham, England, NG7 2UH, United Kingdom
Derriford Hospital | Plymouth, England, PL6 8DH, United Kingdom
Belfast Health and Social Care Trust | Belfast, Northern Ireland, BT12 6BA, United Kingdom
Oxford University Hospitals NHS Foundation Trust | Oxford, Oxfordshire, OX3 9DU, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital | Newcastle Upon Tyne, Tyne And Wear, NE7 7DN, United Kingdom
Abertawe Bro Morganinwg University Local Health Board | Swansea, Wales, SA2 8QA, United Kingdom
Standort Länder

Australia

Canada

France

Germany

Hungary

New Zealand

Poland

Puerto Rico

Spain

Ukraine

United Kingdom

United States

Überprüfungsdatum

July 2020

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 3
Armgruppe

Etikette: Obeticholic Acid (OCA) 10 mg

Art: Experimental

Beschreibung: 10 mg OCA for up to 18 months

Etikette: Obeticholic Acid (OCA) 10 mg to 25 mg

Art: Experimental

Beschreibung: 10 mg OCA for the first 3 months and then may titrate up to 25 mg OCA for the remaining 15 months of the study

Etikette: Placebo

Art: Placebo Comparator

Beschreibung: Placebo for up to 18 months

Akronym REVERSE
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Quelle: ClinicalTrials.gov