Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis
Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
Though ursodeoxycholate acid (UDCA) is the wellknown effective therapy for PBC, clinical
effectiveness of UDCA may be limited by its poor absorption and extensive biotransformation.
The more hydrophilic bile acid tauroursodeoxycholate (TUDCA) is the active ingredients of
UDCA, and has been approved by state food and drug administration in China for treatment of
cholesterol stones. So it is necessary to verify the efficacy and safety of TUDCA in the
treatment of adult primary biliary cirrhosis. In this randomized, double-blinded,
double-dummy, parallel-controlled and multicenter clinical trial, we detect the proportion of
patients who had AKP decline more than 25% as the primary outcome; decline of AKP, total
bilirubin, GGT, ALT and AST as secondary outcomes after patients were treated with TUDCA or
UDCA for 24 weeks.
Phase:
Phase 3
Details
Lead Sponsor:
Beijing Friendship Hospital
Collaborator:
Beijing Trendful Kangjian Medical Information Consulting Limited Company