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NCT05448170 Clinical Trial

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

Pruritus Clinical Trial

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

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT05448170
Other study ID # 217327
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date November 2023
Source GlaxoSmithKline
Contact US GSK Clinical Trials Call Center
Phone 877-379-3718
Email GSKClinicalSupportHD@gsk.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Linerixibat
open label investigational product

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline
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