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

NCT ID: NCT03082885

Last Updated: 2021-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-10
• Study Completion Date: 2019-07-30

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 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.

Conditions

Liver Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Thymosin-α1 group

Patients receive treatment based on standard Therapy with additional Thymosin-α1

Group Type: EXPERIMENTAL

Thymosin-α1

Intervention Type: DRUG

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.

control group

Patients receive treatment based on standard Therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Thymosin-α1

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.

Intervention Type: DRUG

Other Intervention Names

Zadaxin

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Lin Bingliang

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lin B Liang, MD

Role: PRINCIPAL_INVESTIGATOR

leading

Locations

Third Affliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

Thymosin-α1

Identifier Type: -

Identifier Source: org_study_id