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.
Drug: Linerixibat
open label investigational product
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
US GSK Clinical Trials Call Center
877-379-3718
GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center
+44 (0) 20 89904466
GSKClinicalSupportHD@gsk.com
GSK Clinical Trials, Study Director
GlaxoSmithKline