Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
PBC (Primary Biliary Cholangitis)
Enrollment Eligibility
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.