Linerixibat Long-term Safety and Tolerability Study

  • STATUS
    Recruiting
  • End date
    Dec 9, 2024
  • participants needed
    305
  • sponsor
    GlaxoSmithKline
Updated on 23 August 2021
Investigator
US GSK Clinical Trials Call Center
Primary Contact
GSK Investigational Site (8.7 mi away) Contact
+24 other location
cholangitis
cholestatic pruritus

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 duration of the study will be approximately four years until study end, however the total duration of study participation will vary by participant depending upon time of entry relative to study end in their respective country.

Details
Condition Cholestasis
Treatment Linerixibat
Clinical Study IdentifierNCT04167358
SponsorGlaxoSmithKline
Last Modified on23 August 2021

Eligibility

Yes No Not Sure

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 not a woman of childbearing potential (WOCBP) or b) is a WOCBP and using a contraceptive method that is highly effective
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 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
Any current malignancies (including hematologic and solid malignancies)
History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy or ascites)
History of bariatric surgery with ileal bypass at any time, or any bariatric surgery performed in the past 3 years
QT interval corrected (QTc) >480 millisecond (msec) at screening (12-lead ECG)
History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >14 units for males or >7 units for females
Current diagnosis or previous diagnosis of colorectal cancer
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 study withdrawal
Administration of any other ileal bile acid transporter (IBAT) inhibitor in the 1 month prior to screening
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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