MRX-802
Research type
Research Study
Full title
Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Maralixibat in the Treatment of Participants with Cholestatic Pruritus
IRAS ID
1010409
Contact name
Lara Longpre
Contact email
Sponsor organisation
Mirum Pharmaceutical Inc.
Research summary
The MRX-802 study is a multicentre, randomized, double-blind, placebo-controlled study which aims to test a new medicine called maralixibat, which is intended to treat itchiness caused by liver disease, known as cholestatic pruritus. Maralixibat has already shown benefits for patients with two specific liver diseases, Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC). Researchers now want to see if it can help people with other types of liver disease who also experience this kind of itchiness.
Participants are being asked to join this study because they have cholestatic pruritus. The study involves taking maralixibat, a grape-flavored liquid medicine, once or twice a day. Researchers will conduct tests and ask questions about participants' symptoms to determine if maralixibat can provide relief for others with similar conditions.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
24/SW/0091
Date of REC Opinion
5 Nov 2024
REC opinion
Further Information Favourable Opinion