Linerixibat for Itching in Cholangitis
Recruiting at138 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: GlaxoSmithKline
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
This trial is testing a medication called linerixibat to see if it can help reduce severe itching in people with a liver condition called Primary Biliary Cholangitis (PBC). The study will compare the effects of linerixibat to check its effectiveness and safety.
Research Team
GC
GSK Clinical Trials
Principal Investigator
GlaxoSmithKline
Eligibility Criteria
This trial is for adults aged 18-80 with Primary Biliary Cholangitis (PBC) who suffer from moderate to severe itching. Candidates must have documented PBC and cannot have certain liver complications, changes in itch medication within the last 8 weeks, primary sleep disorders, or active viral infections among other exclusions.Inclusion Criteria
I experience moderate to severe itching.
I am between 18 and 80 years old.
You have been diagnosed with primary biliary cholangitis (PBC).
See 1 more
Exclusion Criteria
Your liver test results show very high levels of alanine aminotransferase, which could indicate liver problems.
I do not have ongoing severe diarrhea or active inflammatory bowel disease.
I have a diagnosed sleep disorder like sleep apnea or narcolepsy.
See 14 more
Treatment Details
Interventions
- Linerixibat (Bile Acid Sequestrant)
- Placebo (Drug)
Trial OverviewThe GLISTEN study is testing the effectiveness and safety of a drug called Linerixibat against a placebo in relieving itch caused by PBC. It also looks at how this treatment affects patients' quality of life.
Participant Groups
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Participants receiving placebo followed by linerixibatExperimental Treatment2 Interventions
Group II: Participants receiving linerixibat followed by placeboExperimental Treatment2 Interventions
Group III: Participants receiving linerixibatExperimental Treatment1 Intervention
Group IV: Participants receiving placeboPlacebo Group1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
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Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School