Linerixibat Compassionate Use for Cholestatic Pruritus Adult Patients With Primary Biliary Cholangitis (PBC)

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Available

CT.gov ID

NCT05448170

Collaborator

(none)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pruritus	Drug: Linerixibat

Study Design

Study Type:

Expanded Access

Official Title:

Linerixibat Compassionate Use for Cholestatic Pruritus Adult Patients With Primary Biliary Cholangitis

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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