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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03082885
Other study ID # Thymosin-a1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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