Clinical Trial: Plasma Exchange Combination of Immunosuppressive Regimens for Auto-immune Hepatitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Plasma Exchange Combination of Immunosuppressive Regimens for the Remission of Auto-immune Hepatitis

Brief Summary: An open-label,pilot study to evaluate the efficacy and safety of plasma exchange combination of immunosuppressive regimens, for the remission of autoimmune hepatitis (AIH).

Detailed Summary:
Sponsor: Xiaoli Fan

Current Primary Outcome: Percent of patients that achieve biochemical remission of AIH [ Time Frame: Month 6 after the treatment initiated ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Alanine transaminase (ALT) [ Time Frame: Day 1, and Week 1, 2, 4, 12, 24 ]
  • Aspartate transaminase(AST) [ Time Frame: Day 1, and Week 1, 2, 4, 12, 24 ]
  • Globin(GLB) [ Time Frame: Day 1, and Week 1, 2, 4, 12, 24 ]
  • Immunoglobulin G(IgG) [ Time Frame: Day 1, and Week 1, 2, 4, 12, 24 ]
  • Total bilirubin(TB) [ Time Frame: Day 1, and Week 1, 2, 4, 12, 24 ]
  • Direct bilirubin(DB) [ Time Frame: Day 1, and Week 1, 2, 4, 12, 24 ]


Original Secondary Outcome: Same as current

Information By: West China Hospital

Dates:
Date Received: August 17, 2016
Date Started: December 2016
Date Completion: September 2017
Last Updated: December 8, 2016
Last Verified: December 2016