A randomized controlled trial to evaluate efficacy and safety of Thymosin-α1 administration in patients with HBV-related Acute-on-chronic liver failure.
Hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) is a severe disease with high mortality. In this study, the investigators intend to assess the efficacy and safety of Thymosin-α1 in patients with HBV-related Acute-on-chronic liver failure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
1.6 mg s.c injection once per day for 7 days, then 1.6 mg s.c injection twice a week for 11 weeks.
Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The liver transplantation-free survival rate of 90 days
Survival condition of the patients were observed for 90 days
Time frame: 90 days
The liver transplantation-free survival rate of 180 days
Survival condition of the patients were observed for 180 days
Time frame: 180 days
Number of participants with ferver, bleeeding of injection site, amyotrophy and arthralgia
Fever, bleeeding of injection site, amyotrophy and arthralgia were observed during the treatment in both group.
Time frame: 24 weeks
Complications after 48 hours admission
Occurence of encephalopathy, infection, bleeding,hepatorenal syndrome after 48 hours admission.
Time frame: 24 weeks
Hepatitis B virus DNA load change
Hepatitis B virus DNA were measured on week 0, 4,8,12 and 24 after the start of the infusion in both groups
Time frame: 24 weeks
Causes of death/liver transplantation
Causes of death/liver transplantation (e.g. liver failure, multiple organs failure, severe infection) were recorded in both groups.
Time frame: 24 weeks
Inflammatory indexes change
Inflammatory indexes were measured on week0,1,2, 4,8,12 and 24 after the start of the infusion in both groups
Time frame: 24 weeks
Alanine aminotransferase change
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Levels of alanine aminotransferase were measured on week0,1,2, 4,8, 12 and 24 after the start of the infusion in both groups
Time frame: 24 weeks
Glutamic oxaloacetic transaminase change
Levels of glutamic oxaloacetic transaminase were measured on week0,1,2, 4,8, 12 and 24 after the start of the infusion in both groups
Time frame: 24 weeks
Total bilirubin change
Levels of total bilirubin were measured on week0,1,2, 4,8,12 and 24 after the start of the infusion in both groups
Time frame: 24 weeks
Plasma thrombin time change
Levels of plasma thrombin time were measured on week0,1,2, 4,8,12 and 24 after the start of the infusion in both groups
Time frame: 24 weeks
Albumin time change
Levels of albumin were measured on week0,1,2, 4,8, 12 and 24 after the start of the infusion in both groups
Time frame: 24 weeks