Linerixibat: All participants will receive linerixibat.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Number of participants with non-serious adverse events (AEs) and Serious AEs (SAEs) — Up to 66 months AEs and SAEs will be collected.
Number of participants with Severe AEs — Up to 66 months AEs and SAEs will be collected.
Trial sites (94)
Facility
City
Region
Status
GSK Investigational Site
Davis
California
GSK Investigational Site
West Hollywood
California
GSK Investigational Site
Miami
Florida
GSK Investigational Site
Detroit
Michigan
GSK Investigational Site
New York
New York
GSK Investigational Site
Durham
North Carolina
GSK Investigational Site
Morrisville
North Carolina
GSK Investigational Site
Philadelphia
Pennsylvania
GSK Investigational Site
Dallas
Texas
GSK Investigational Site
Houston
Texas
GSK Investigational Site
Seattle
Washington
GSK Investigational Site
Buenos Aires
Argentina
GSK Investigational Site
Capital Federal
Argentina
GSK Investigational Site
Ciudad AutOnoma de Buenos Aire
Argentina
GSK Investigational Site
Ciudad Autonoma de Bueno
Argentina
GSK Investigational Site
Rosario
Argentina
GSK Investigational Site
Santa Fe
Argentina
GSK Investigational Site
Porto Alegre
Rio Grande do Sul
GSK Investigational Site
Botucatu
Brazil
GSK Investigational Site
Brasília
Brazil
GSK Investigational Site
Salvador
Brazil
GSK Investigational Site
Sofia
Bulgaria
GSK Investigational Site
Edmonton
Alberta
GSK Investigational Site
Toronto
Ontario
GSK Investigational Site
Beijing
China
GSK Investigational Site
Beijing
China
GSK Investigational Site
Changchun
China
GSK Investigational Site
Chongqing
China
GSK Investigational Site
Guangzhou
China
GSK Investigational Site
Nanchang
China
GSK Investigational Site
Nanjing
China
GSK Investigational Site
Shanghai
China
GSK Investigational Site
Tianjin
China
GSK Investigational Site
Pilsen
Czechia
GSK Investigational Site
Prague
Czechia
GSK Investigational Site
Lille
France
GSK Investigational Site
Erlangen
Germany
GSK Investigational Site
Münster
Germany
GSK Investigational Site
Haifa
Israel
GSK Investigational Site
Holon
Israel
+ 54 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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