Linerixibat Long-term Safety and Tolerability Study
Research type
Research Study
Full title
Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis
IRAS ID
279425
Contact name
David Jones
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Ltd
Eudract number
2019-003158-10
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND# , 130391
Duration of Study in the UK
4 years, 0 months, 27 days
Research summary
GSK is conducting a study to evaluate the safety and tolerability of long-term linerixibat (GSK2330672)for the treatment of moderate to severe pruritus in adults with primary biliary cholangitis (PBC) who previously participated in linerixibat studies BAT117213 or 201000.
PBC is a rare condition where the bile ducts in the liver become damaged. This causes the build-up of bile acid salts in the body which causes patients to experience persistent itching (pruritus). Current pruritus treatments show variable efficacy, have some unpleasant side-effects and interact with one of the main treatments for PBC ursodeoxycholic acid (UDCA).
GSK2330672 blocks bile from re-entering the blood and causes it to be excreted instead, which may lessen pruritus. It is hoped lower bile acid levels in the liver may improve the course of the underlying disease.
The study aims to assess the long-term safety and tolerability of GSK2330672. The study also aims to assess any improvements in pruritus and its effect on participants wellbeing. Participants will receive 90mg of GSK2330672 as tablets twice daily for approximately 4 years until study end or linerixibat can be lawfully made available to patients. Participants will have a phone call after 1 week, 1 month, & 2 months of study start. Participants will have a site visit every 3 months during the first year of the study, then site visits once every 6 months for the remainder of the study. Participants will also have a follow-up phone call 7-14 days after last study visit. Participants may receive some PBC and itch therapies including UDCA; some other treatments for itch are not allowed.
Assessments include: medical history, physical exam, vital signs, ECG, pregnancy test (if applicable), stool samples, & blood tests. At each visit participants will complete up to 3 questionnaires on PBC and its impact.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
20/SC/0223
Date of REC Opinion
4 Jun 2020
REC opinion
Favourable Opinion