Efficacy and Safety Study of TUDCA Compare UDCA to Treatment Chronic Cholestatic Liver Disease-PBC
Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
Participant gender:
Summary
Though ursodeoxycholate acid (UDCA) is the well known effective therapy for PBC,clinical
effectiveness of UDCA may be limited by its poor absorption and extensive
biotransformation.The more hydrophillic 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 ALP,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 Trendful Kangjian Medical Information Consulting Limited Company