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 ]

Biochemical remission is defined as alanine transaminase(ALT),aspartate transaminase(AST) and immunoglobulin G(IgG) within normal limits


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