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

Liver Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03082885
• Other study ID #: Thymosin-a1
• Status: Completed
• Phase: N/A
• Start date: April 10, 2017
• Est. completion date: July 30, 2019

Study information

• Verified date: August 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 30, 2019
• Est. primary completion date: June 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Insufficiency
• Liver Failure

Intervention

Drug:
• Thymosin-a1
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.

Locations

Country	Name	City	State
China	Third Affliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The liver transplantation-free survival rate of 90 days	Survival condition of the patients were observed for 90 days	90 days
Secondary	The liver transplantation-free survival rate of 180 days	Survival condition of the patients were observed for 180 days	180 days
Secondary	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
Secondary	Complications after 48 hours admission	Occurence of encephalopathy, infection, bleeding,hepatorenal syndrome after 48 hours admission.	24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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