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Active, not recruiting Phase 3

Linerixibat Long-term Safety, and Tolerability Study

NCT04167358 · tracked via the Priya Life Science Italy tracker
Phase
Phase 3
Started
2020-07-14
Last updated
2026-06-22

Condition(s) studied

Cholestasis

Investigational drug(s) / intervention(s)

Linerixibat

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)

FacilityCityRegionStatus
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.

Official registry record

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.

View NCT04167358 on ClinicalTrials.gov ↗ ← All trials in Italy