Clinical Trial: Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical Trial to Investigate Safety and Efficacy of Tauroursodeoxycholic Acid Capsules in Treatment of Adult

Brief 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.

Detailed Summary:
Sponsor: Beijing Friendship Hospital

Current Primary Outcome: The proportion of patients who had AKP decline more than 25% after 24 weeks treatment of UDCA [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • ALP decline from baseline after 24 weeks treatment of TUDCA [ Time Frame: 12 month ]
  • Total bilirubin decline from baseline after 24 weeks treatment of TUDCA [ Time Frame: 12 months ]
  • GGT decline from baseline after 24 weeks treatment of TUDCA [ Time Frame: 12 months ]
  • ALT and AST decline from baseline after 24 weeks treatment of TUDCA [ Time Frame: 12 months ]


Original Secondary Outcome: Same as current

Information By: Beijing Friendship Hospital

Dates:
Date Received: May 16, 2013
Date Started: September 2009
Date Completion:
Last Updated: May 16, 2013
Last Verified: May 2013