Clinical Trial: Paeoniflorin Combination of Hepatoprotective Drugs Versus Hepatoprotective Drugs Only for Auto-immune Hepatitis
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Paeoniflorin Combination of Hepatoprotective Drugs Versus Hepatoprotective Drugs Only for Treatment of Auto-immune Hepatitis
Brief Summary: An open-label,prospective, randomized pilot study to evaluate the efficacy, safety and tolerability of paeoniflorin, for the treatment of autoimmune hepatitis (AIH) with mild necroinflammatory activity on liver biopsy.
Detailed Summary:
Sponsor: Xiaoli Fan
Current Primary Outcome: Percent of patients that achieve biochemical remission of AIH [ Time Frame: Month 6 during treatment with paeoniflorin combination of hepatoprotective drugs or hepatoprotective drugs only ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Alanine transaminase (ALT) [ Time Frame: Month 1, 3, 6 ]
- Aspartate transaminase(AST) [ Time Frame: Month 1, 3, 6 ]
- Immunoglobulin G(IgG) [ Time Frame: Month 1, 3, 6 ]
- Globin(GLB) [ Time Frame: Month 1, 3, 6 ]
- Total bilirubin(TB) [ Time Frame: Month 1, 3, 6 ]
- Direct bilirubin(DB) [ Time Frame: Month 1, 3, 6 ]
Original Secondary Outcome: Same as current
Information By: West China Hospital
Dates:
Date Received: August 9, 2016
Date Started: August 2016
Date Completion: July 2017
Last Updated: August 21, 2016
Last Verified: August 2016