Norursodeoxycholic acid vs. Placebo in PSC
Research type
Research Study
Full title
Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis
IRAS ID
229417
Contact name
Palak Trivedi
Contact email
Sponsor organisation
Dr. Falk Pharma GmbH
Eudract number
2016-003367-19
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
6 years, 2 months, 17 days
Research summary
The aim of the research study is to compare the intake of once daily oral norursodeoxycholic acid with once daily intake of placebo (capsules without active drug) for the treatment of primary sclerosing cholangitis. This is done by putting patients into two different treatment groups. The results of both groups are then compared. The treatment is double-blind.
Norursodeoxycholic acid (norUDCA) is a new drug, currently under investigation for the treatment of PSC.
Patient’s participation in this study will last up to 202 weeks. The study will begin with a Screening Visit (Visit 1), which will take place between 4 and 8 weeks before start of treatment to check whether medical status of patient fulfils all criteria for the study. Then, a Baseline Visit (Visit 2) will be performed and the treatment with study medication will be started. The total duration of treatment will be 192 weeks. During the first 96 weeks 12 control visits including an end of treatment visit are scheduled. The treatment period will be followed immediately by a second 96-week treatment period (extension phase). During the extension phase, patient will visit the study doctor every 3 months, i.e. 8 times including a final end of treatment visit.
It is planned to include a total of 300 patients with PSC from several European countries into this study.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
17/YH/0391
Date of REC Opinion
22 Dec 2017
REC opinion
Further Information Favourable Opinion