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.

Study Overview

• Status: Completed
• Conditions: Liver Failure
• Intervention / Treatment: Drug: Thymosin-α1

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • Third Affliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Thymosin-α1 group; Patients receive treatment based on standard Therapy with additional Thymosin-α1	Drug: 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.; Other Names: Zadaxin
NO_INTERVENTION: control group; Patients receive treatment based on standard Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The liver transplantation-free survival rate of 90 days	Survival condition of the patients were observed for 90 days	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The liver transplantation-free survival rate of 180 days	Survival condition of the patients were observed for 180 days	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.	24 weeks
Complications after 48 hours admission	Occurence of encephalopathy, infection, bleeding,hepatorenal syndrome after 48 hours admission.	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	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.	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	24 weeks
Alanine aminotransferase change	Levels of alanine aminotransferase were measured on week0,1,2, 4,8, 12 and 24 after the start of the infusion in both groups	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	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	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	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	24 weeks

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Lin B Liang, MD, leading

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 10, 2017
• Primary Completion (ACTUAL): June 2, 2019
• Study Completion (ACTUAL): July 30, 2019

Study Registration Dates

• First Submitted: February 23, 2017
• First Submitted That Met QC Criteria: March 12, 2017
• First Posted (ACTUAL): March 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2021
• Last Update Submitted That Met QC Criteria: August 8, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Liver Failure; Hepatic Insufficiency; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Thymalfasin
• Other Study ID Numbers: Thymosin-α1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No