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 ]
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