The Efficacy and Safety of Thymosin-α1 in Patients With HBV-related ACLF

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

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.

Inclusion Criteria:

• 1.Chronic hepatitis B.(Hepatitis B surface antigen positive for more than 6 months or having evidence of chronic hepatitis B virus infection).
• 2.Defined by an acute deterioration in transaminase greater than or equal to 5 times upper normal limit over14 days.
• 3.Development of jaundice (serum bilirubin greater than or equal to 10mg/dl).
• 4.Development of coagulopathy(PTA≤40% or INR≥1.5 ).
• More than one of the 5-8 criteria：
• 5.Development of hepatic encephalopathy.
• 6.Development of hepatorenal syndrome.
• 7.Hepatic narrowing progressively.
• 8.Development of massive ascites or peritonitis.
• 9. Willing to provide informed consent and comply with the test requirements

Exclusion Criteria:

• 1.Patients who have hepatocellular carcinoma confirmed by ultrasound/CT/MR.
• 2.Patients who have autoimmune disease (such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, etc ) or with abnormal elevation level of autoimmune antibody.
• 3.Model for end-stage liver disease (MELD) score <17 or >35.
• 4.Patients with significant co-morbid illnesses such as cardiovascular or respiratory or intrinsic renal diseases which by themselves may have a bearing on the outcome.
• 5.Patients with diseases that researchers consider inappropriate to participate in the study.
• 6.Patients who have disseminated intravascular coagulation.
• 7.Drug allergy.
• 8.Patients with any other contraindications to thymosin alpha1.
• 9.Patients who participated in other clinical trials at the same time.