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

• Status: Completed
• Trial end date: 2019-07-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Thymalfasin

Criteria

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.