Clinical Trial: The Efficacy and Safety of Thymosin-α1 in Patients With HBV-related ACLF.

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Randomized Controlled Trial to Evaluate Efficacy and Safety of Thymosin-α1 Administration in Patients With HBV-related Acute-on-chronic Liver Failure

Brief Summary: A randomized controlled trial to evaluate efficacy and safety of Thymosin-α1 administration in patients with HBV-related Acute-on-chronic liver failure.

Detailed Summary: Hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) is a severe disease with high mortality. In this study, we intend to assess the efficacy and safety of Thymosin-α1 in patients with HBV-related Acute-on-chronic liver failure.
Sponsor: Sun Yat-sen University

Current Primary Outcome: The survival rate of 24 weeks [ Time Frame: 24 weeks ]

survival condition of the patients were observed for 24 weeks


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Liver function change [ Time Frame: 24 weeks ]
    Child-Pugh, MELD and CLIP-SOFA score was measured on week0, 4,12and 24 after the start of the infusion in both groups
  • Immune response to Thymosin-α1 [ Time Frame: 24 weeks ]
    HLA-DR expression on NK cell on week0, 4,12and 24 after the start of the infusion in both groups


Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: February 23, 2017
Date Started: March 18, 2017
Date Completion: March 31, 2019
Last Updated: March 12, 2017
Last Verified: March 2017