Linerixibat Long-term Safety, and Tolerability Study (LLSAT)

November 3, 2023 updated by: GlaxoSmithKline

Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis

This is an open-label, non-comparator, global, multi-center, long-term safety study for evaluating safety and tolerability of linerixibat in participants with cholestatic pruritus in primary biliary cholangitis (PBC) who participated in a prior clinical trial with linerixibat (BAT117123 [NCT01899703], 201000 GLIMMER [NCT02966834] (group 1) or 212620 GLISTEN [NCT00210418]) (group 2). All participants will receive open-label linerixibat for the duration of the study. The study duration is expected to last until the study's end or until linerixibat can be lawfully made available to participants. However, the total duration of study participation will vary by participant depending upon the time of entry relative to study end in their respective country.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

305

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1118
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nora Gabriela Cejas
      • Buenos Aires, Argentina, C1056ABJ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Margarita Anders
      • Santa Fe, Argentina, 3000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Luis Alejandro Gaite
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1061AAS
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fernando Mario Gruz
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1181ACI
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Alejandra Villamil
        • Contact:
        • Contact:
      • San Nicolas, Buenos Aires, Argentina, B2900DMH
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cesar Andres Pezzoto
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2002KDT
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fernando Oscar Bessone
  • Belgium
      • Brussels, Belgium, 1070
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christophe Moreno
      • Gent, Belgium, 9000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xavier Verhelst
  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 40110-160
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Simone da Cunha
    • Goiás
      • Brasilia, Goiás, Brazil, 70335-900
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Liliana Mendes
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035003
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mario da Silva
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18618686
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fernando Gomes Romeiro
  • Bulgaria
      • Plovdiv, Bulgaria, 4004
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rayna Sokolova
      • Sofia, Bulgaria, 1618
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dimitar Dimitrov
      • Sofia, Bulgaria
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kamen Danov
      • Sofia, Bulgaria, 1463
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Konstantin Tchernev
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gideon Hirschfield
    • Quebec
      • Montréal, Quebec, Canada, H2X 0A9
        • Withdrawn
        • GSK Investigational Site
  • China
      • Beijing, China, 100032
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jidong Jia
      • Beijing, China, 100069
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yanmin Liu
      • Shanghai, China, 200127
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiong Ma
      • Tianjin, China
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tao Han
      • Xi'an, China, 710061
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yingren Zhao
      • Zhengzhou, China, 450000
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jia Shang
        • Contact:
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bingliang Lin
      • Zhanjiang, Guangdong, China, 524000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Huanqin Han
    • Jiangsu
      • Nanjing, Jiangsu, China, 210003
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yandan Zhong
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiaoping Wu
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Qinglong Jin
    • Sichuan
      • Chongqing, Sichuan, China, 400042
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dachuan Cai
  • Czechia
      • Ostrava, Czechia, 708 52
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adam Vasura
      • Plzen, Czechia, 30100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vaclav Hejda
      • Praha 4, Czechia, 140 21
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jan Sperl
  • France
      • Lille cedex, France, 59037
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alexandre Louvet
  • Germany
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marcel Vetter
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45147
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sandra Christoph
      • Muenster, Nordrhein-Westfalen, Germany, 48149
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sonja Staender
  • Greece
      • Athens, Greece, 115 27
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Spilios Manolakopoulos
  • Israel
      • Beer Sheva, Israel, 84101
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ohad Etzion
      • Haifa, Israel, 34362
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Matthias Carlebach
      • Haifa, Israel, 31096
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ella Veitsman
      • Holon, Israel, 58100
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Vera Dreizin
        • Contact:
        • Contact:
      • Jerusalem, Israel, 91120
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rifaat Safadi
      • Nahariya, Israel, 22100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michal Carmiel
      • Ramat Gan, Israel, 52621
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ziv Ben-Ari
      • Rehovot, Israel, 76100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yaakov Maor
  • Italy
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy, 41126
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pietro Andreone
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Luca Miele
    • Lombardia
      • Milano, Lombardia, Italy, 20142
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Massimo Zuin
      • Monza, Lombardia, Italy, 20900
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pietro Invernizzi
      • Rozzano, Lombardia, Italy, 20089
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ana Lleo De Nalda
    • Veneto
      • Negrar Di Valpolicella, Veneto, Italy, 37024
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paolo Bocus
      • Padova, Veneto, Italy, 35128
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Nora Cazzagon
        • Contact:
        • Contact:
  • Japan
      • Chiba, Japan, 270-1694
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Tomomi Okubo
        • Contact:
        • Contact:
      • Ehime, Japan, 791-0295
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Masanori Abe
      • Fukui, Japan, 918-8503
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kazuo Notsumata
      • Gunma, Japan, 371-8511
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yuichi Yamazaki
      • Hiroshima, Japan, 730-8619
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Keiji Tsuji
      • Hiroshima, Japan, 734-8551
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michio Imamura
      • Hokkaido, Japan, 006-8555
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kunihiko Tsuji
      • Kagawa, Japan, 760-8557
        • Completed
        • GSK Investigational Site
      • Kanagawa, Japan, 259-1143
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tatehiro Kagawa
      • Nagano, Japan, 390-8621
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Takeji Umemura
      • Nagasaki, Japan, 856-8562
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Atsumasa Komori
      • Nara, Japan, 634-8522
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tadashi Namisaki
      • Osaka, Japan, 545-8586
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sawako Uchida
        • Contact:
        • Contact:
      • Osaka, Japan, 591-8025
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Naoki Hiramatsu
        • Contact:
        • Contact:
      • Shizuoka, Japan, 431-3192
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kazuhito Kawata
      • Tokyo, Japan, 162-8655
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mikio Yanase
      • Tokyo, Japan, 173-8606
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Atsushi Tanaka
      • Tokyo, Japan, 113-8603
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Masanori Atsukawa
      • Tokyo, Japan, 181-8611
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Naohiro Kawamura
        • Contact:
        • Contact:
  • Mexico
    • Ciudad De Mexico
      • Mexico City, Ciudad De Mexico, Mexico, 14080
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ricardo Ulises Macias-Rodriguez
      • Mexico, City, Ciudad De Mexico, Mexico, 06700
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alma Laura Ladron de Guevara- Cetina
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64020
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Linda Elsa Muñoz-Espinosa
  • Poland
      • Czestochowa, Poland, 42-217
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Krzysztof Janik
      • Katowice, Poland, 40-659
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Aldona Mularczyk
        • Contact:
        • Contact:
      • Myslowice, Poland, 41-400
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ewa Janczewska
      • Warszawa, Poland, 03-712
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jan Gietka
      • Wroclaw, Poland, 51-162
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Krzysztof Simon
  • Russian Federation
      • Kemerovo, Russian Federation, 650000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Svetlana Smakotina
      • Moscow, Russian Federation, 119121
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria S. Zharkova
      • Samara, Russian Federation, 443063
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elena Malova
  • Spain
      • Valencia, Spain, 46026
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Victoria Aguilera Sancho-Tello
        • Contact:
        • Contact:
  • Switzerland
      • Lugano, Switzerland, 6900
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Benedetta Terziroli
  • United Kingdom
      • Basingstoke, United Kingdom, RG24 9NA
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • John Ramage
      • Cambridge, United Kingdom, CB2 0QQ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • George Mells
      • Glasgow, United Kingdom, G31 2ER
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stephen Barclay
      • Hull, United Kingdom, HU3 2JZ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lynsey Corless
      • Liverpool, United Kingdom, L9 7AL
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Margaret Corrigan
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Douglas Thorburn
      • Newcastle Upon Tyne, United Kingdom, NE4 5PL
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Emrys Jones
      • Nottingham, United Kingdom, NG7 2UH
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Stephen Ryder
        • Contact:
        • Contact:
      • Plymouth, United Kingdom, PL6 8DH
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Sheridan
      • Reading, United Kingdom, RG1 5AN
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Harman
      • Southampton, United Kingdom, SO16 6YD
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Janisha Patel
    • Surrey
      • Redhill, Surrey, United Kingdom, RH1 5RH
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gayatri Chakrabarty
  • United States
    • California
      • Culver City, California, United States, 90230
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Debra Weinstein
      • Los Angeles, California, United States, 90048
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Walid S Ayoub
      • Sacramento, California, United States, 95817
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christopher Bowlus
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bhaktasharan Patel
    • Florida
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Agustin Martinez
      • Miami, Florida, United States, 33136
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cynthia Levy
    • Michigan
      • Novi, Michigan, United States, 48377
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stuart Gordon
    • Nebraska
      • Omaha, Nebraska, United States, 68198-2000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fedja A Rochling
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ira M Jacobson
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrew J Muir
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Khalid Mumtaz
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marlyn Mayo
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Kris V Kowdley
        • Contact:
        • Contact:

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and female participants must be 18 to 80 years of age inclusive, at the time of signing the informed consent in the participant's parent trial BAT117213, GLIMMER or GLISTEN.
  • Participants with a diagnosis of PBC and a history of associated pruritus as evidenced by randomization into a prior eligible linerixibat clinical trial (BAT117213, GLIMMER or GLISTEN).
  • Participants must have completed the main treatment period in a prior eligible linerixibat clinical trial (BAT117213, GLIMMER or GLISTEN).
  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: a) is a woman of non-childbearing potential (WONCBP) or b) is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method.
  • Capable of giving signed informed consent.

Exclusion Criteria:

  • Screening total bilirubin >2x upper limit of normal (ULN).
  • Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >6x ULN.
  • Screening estimated glomerular filtration rate (eGFR) <30 milliliters per minute per 1.73 square meter (mL/min/1.73m^2) based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
  • Presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy or ascites).
  • Presence of actively replicating viral hepatitis B or C (Viral Hepatitis B [HBV], viral Hepatitis C [HCV]) infection), primary sclerosing cholangitis (PSC), alcoholic liver disease and/or confirmed hepatocellular carcinoma or biliary cancer.
  • Current clinically significant diarrhea in the Investigator's medical opinion.
  • Current symptomatic cholelithiasis or cholecystitis.
  • Current diagnosis or previous diagnosis of colorectal cancer.
  • Any current malignancies (including hematologic and solid malignancies).
  • History of bariatric surgery with ileal bypass at any time, or any bariatric surgery performed in the past 3 years.
  • Use of Obeticholic acid: within 8 weeks prior to the date of the screening visit and may not restart until after the end of the study or early study withdrawal.
  • Administration of any other ileal bile acid transporter (IBAT) inhibitor in the 1 month prior to screening until after the end of the study or early study withdrawal.
  • QT interval corrected (QTc) >480 millisecond (msec) at screening (12-lead ECG)
  • Participants with moderate (or greater) alcohol consumption defined as more than one standard drink per day for women and two drinks per day for men.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants receiving linerixibat
Participants who previously participated in the Phase 2 studies (BAT117213 and 201000 GLIMMER [Group 1]) and Phase 3 study (212620 GLISTEN [Group 2]), will receive linerixibat.
Drug: Linerixibat
All participants will receive linerixibat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with non-serious adverse events (AEs) and Serious AEs (SAEs)
Time Frame: Up to 66 months
AEs and SAEs will be collected.
Up to 66 months
Number of participants with Severe AEs
Time Frame: Up to 66 months
AEs and SAEs will be collected.
Up to 66 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in domain scores of the PBC-40 over time
Time Frame: Baseline and up to 65 months
The PBC-40 is a participant-derived, disease specific health-related quality of life (QoL) measure with data to support its validity in PBC. The PBC-40 measure is comprised of 40 questions, each scored on a scale of 1 to 5 (where 1 = least impact, 5 = greatest impact) grouped into six domains (symptoms, itch, fatigue, cognition, social, and emotional).
Baseline and up to 65 months
Change in health-related quality of life (QoL) by the Euro Quality-5 dimension-3 level (EQ-5D-3L) scores over time (Group 1 only)
Time Frame: Baseline and up to 65 months
The EQ-5D-3L is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ Visual Analogue Scale (VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: 1=no problems, 2=some problems, and 3=extreme problems.
Baseline and up to 65 months
Change in self-rated health by EQ VAS scores over time (Group 1 only)
Time Frame: Baseline and up to 65 months
The EQ-5D-3L is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The EQ VAS records self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.
Baseline and up to 65 months
Change in the Beck Depression Inventory (BDI-II) scores over time
Time Frame: Baseline and up to 65 months
The BDI-II is a 21-item questionnaire used to assess the intensity of depression in clinical and normal participants. Each item is scored from 0 (Normal) to 3 (Severe). The total score on the BDI-II ranges from 0-63, with higher scores reflecting higher levels of depression.
Baseline and up to 65 months
Number of participants with clinically significant changes in hematology, biochemistry (including lipid and liver parameters), and coagulation parameters
Time Frame: Baseline and up to 65 months
Blood samples will be collected for the analysis of hematology, biochemistry (including lipid and liver parameters) and coagulation parameters.
Baseline and up to 65 months
Percentage of responders at Week 24 and Week 52 of continuous treatment (Group 2 only)
Time Frame: Week 24 and Week 52 of continuous treatment
Monthly Itch Score (MIS) will be assessed using an numerical rating scale (NRS), ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. Response thresholds of greater than or equal to (>=) 2, >=3, and >=4-point reduction in MIS will be assessed.
Week 24 and Week 52 of continuous treatment
Percentage of participants with maintenance of efficacy at Week 52 of continuous treatment in those that were responders at Week 24 of continuous treatment (Group 2 only)
Time Frame: Week 52 of continuous treatment
The MIS will be assessed using an NRS, ranging from 0 to 10, where 0 represents no itching and 10 the worst imaginable itching. Maintenance of efficacy occurs when a participant is a responder (>=2, >=3, and >=4-point reduction in MIS) at Week 24 of continuous treatment and is also a responder at Week 52 of continuous treatment.
Week 52 of continuous treatment
Change from Baseline Monthly Sleep Score (MSS) (Group 2 only)
Time Frame: Baseline and up to Week 52 of continuous treatment
The MSS will be assessed using an NRS, ranging from 0 to 10, where 0 represents no sleep interference and 10 is complete sleep interference. This will be assessed at Week 52 of continuous treatment.
Baseline and up to Week 52 of continuous treatment
Change from Baseline in Monthly Fatigue Score (MFS)(Group 2 only)
Time Frame: Baseline and up to Week 52 of continuous treatment
The MFS will be assessed using an NRS, ranging from 0 to 10, where 0 represents no fatigue and 10 the worst possible fatigue. This will be assessed at Week 52 of continuous treatment.
Baseline and up to Week 52 of continuous treatment

Collaborators and Investigators

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

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

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)

July 14, 2020

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

February 2, 2027

Study Registration Dates

First Submitted

November 15, 2019

First Submitted That Met QC Criteria

November 15, 2019

First Posted (Actual)

November 18, 2019

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 212358
  • 2019-003158-10 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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