UDCA plus budesonide vs. UDCA alone in PBC patients
Research type
Research Study
Full title
Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis
IRAS ID
3692
Sponsor organisation
Dr. Falk Pharma GmbH
Eudract number
2007-004040-70
Clinicaltrials.gov Identifier
Research summary
Primary Biliary Cirrhosis (PBC) is a presumed autoimmune disease of the liver which predominantly affects middle-aged women. The disease generally progresses slowly, without treatment, but survival is less than in an age and gender-matched healthy population. The mean life expectancy is about 10 years if no treatment is initiated.Ursodeoxycholic acid (UDCA) monotherapy is the only approved therapy for PBC. The therapy is most effective, if started at early stages of the disease. This international, multi-centre clinical trial is funded by Dr. Falk Pharma GmbH, Germany, and aims to compare the efficacy and safety of the combination of UDCA plus budesonide with the combination of UDCA plus placebo in the treatment of PBC. The treatment period will be 3 years. It is planned to enrol patients at risk for a disease progression, i.e. non-responsive to UDCA therapy. Alternative new therapeutic options are warranted for this patient population. Budesonide seems a suitable add on therapy.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
09/H0907/6
Date of REC Opinion
1 Jun 2009
REC opinion
Further Information Favourable Opinion