Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)

Sex: All

Ages: 18 Years – 80 Years

Healthy volunteers: No

Phase: PHASE3

Enrollment: 238

Sponsor: GlaxoSmithKline

Summary

This is a 2-part study in PBC participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.

Eligibility Criteria

Inclusion Criteria: * Male and female participants must be between 18 to 80 years of age inclusive, at the time of signing the informed consent. * Participants who have documented PBC. * Participants who have moderate to severe itch. Exclusion Criteria: * Total bilirubin \>2.0 times Upper Limit of Normal (ULN) using the average of two Baseline measures. * Screening Alanine Aminotransferase (ALT) \> 6 times ULN in a single Baseline measure or ALT \> 5 times ULN using the average of two Baseline measures. * Screening estimated glomerular filtration rate (eGFR) \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04950127). StuddyBuddy aggregates publicly available trial information.