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

Sun Yat-sen University

Status

Completed

Conditions

Liver Failure

Treatments

Drug: Thymosin-α1

Study type

Interventional

Funder types

Other

Identifiers

NCT03082885

Thymosin-α1

Details and patient eligibility

About

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

Full description

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.

Enrollment

120 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.
1. 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.