Official Title
Linerixibat Compassionate Use for Cholestatic Pruritus Adult Patients With Primary Biliary Cholangitis
Brief Summary

The goal of this compassionate use program is to provide a mechanism to supply linerixibat, on an individual named patient basis. This program is for treatment of individuals who have moderate/severe cholestatic pruritus associated to PBC who have failed available treatment options and are unable or do not qualify to participate in the linerixibat Phase III clinical studies.

Individual Patients

Drug: Linerixibat
open label investigational product

Eligibility Criteria

Inclusion Criteria: - Participants with moderate/severe cholestatic pruritus associated to PBC who are unable to participate or do not qualify for enrollment in the ongoing linerixibat phase 3 clinical trials (NCT04167358 and NCT04950127 studies) - Male and female ≥ 18 years of age - Participants who have failed available treatment alternatives for cholestatic pruritus in PBC - Contraceptive/Barrier Requirements (applicable for female participants only):

A female participant is eligible if she is not pregnant or breastfeeding, and at least one
of the following conditions applies: - Is not a woman of childbearing potential (WOCBP) OR - Is a WOCBP and using an acceptable contraceptive method during the treatment with linerixibat and for at least 4 weeks after the last dose of linerixibat.

Exclusion Criteria: - Advanced chronic liver disease (e.g. cirrhosis Child-Pugh C) or presence of hepatic decompensation (e.g. variceal bleeding, encephalopathy). - Use of obeticholic acid or other IBAT inhibitor

Eligibility Gender
Eligibility Age
Minimum: 18 Years

US GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Center
+44 (0) 20 89904466

GSK Clinical Trials
Study Director

NCT Number
Individual Patient Compassionate Use
Primary Biliary Cholangitis
Ileal bile acid transporter (IBAT) inhibitor
MeSH Terms
Liver Cirrhosis, Biliary