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

NCT05448170 | Unknown

• 1 other identifier: 217327
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 cholestatic pruritus associated with PBC who are deemed at high risk of a significant clinical event as a result of their pruritus and for whom all available pharmaceutical treatment options for cholestatic pruritus have been unsuccessful or are considered to not be appropriate.

Conditions

Pruritus

Keywords

Linerixibat; Individual Patient Compassionate Use; Primary Biliary Cholangitis; Ileal bile acid transporter (IBAT) inhibitor

Interventions

Linerixibat DRUG

open label investigational product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with cholestatic pruritus associated to PBC identified by their healthcare provider as being at high risk of a significant clinical event as a result of their pruritus.
• Male and female \>= 18 years of age.
• Participants for whom all available pharmaceutical treatments for cholestatic pruritus in PBC have been unsuccessful or are considered to not be appropriate.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Pruritus; Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 7, 2022
• Last Updated: February 27, 2025

Record last verified: 2025-02