Back to resultsThe Efficacy and Safety of Thymosin-α1 in Patients With HBV-related ACLF
Primary Purpose
Liver Failure
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Thymosin-α1
Sponsored by
About this trial
This is an interventional treatment trial for Liver Failure
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.
Sites / Locations
- Third Affliated Hospital of Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Thymosin-α1 group
control group
Arm Description
Patients receive treatment based on standard Therapy with additional Thymosin-α1
Patients receive treatment based on standard Therapy
Outcomes
Primary Outcome Measures
The liver transplantation-free survival rate of 90 days
Survival condition of the patients were observed for 90 days
Secondary Outcome Measures
The liver transplantation-free survival rate of 180 days
Survival condition of the patients were observed for 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.
Complications after 48 hours admission
Occurence of encephalopathy, infection, bleeding,hepatorenal syndrome after 48 hours admission.
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
Causes of death/liver transplantation
Causes of death/liver transplantation (e.g. liver failure, multiple organs failure, severe infection) were recorded in both groups.
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
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
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
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
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
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
Full Information
NCT ID
NCT03082885
First Posted
February 23, 2017
Last Updated
August 8, 2021
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT03082885
Brief Title
The Efficacy and Safety of Thymosin-α1 in Patients With HBV-related ACLF
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 10, 2017 (Actual)
Primary Completion Date
June 2, 2019 (Actual)
Study Completion Date
July 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thymosin-α1 group
Arm Type
Experimental
Arm Description
Patients receive treatment based on standard Therapy with additional Thymosin-α1
Arm Title
control group
Arm Type
No Intervention
Arm Description
Patients receive treatment based on standard Therapy
Intervention Type
Drug
Intervention Name(s)
Thymosin-α1
Other Intervention Name(s)
Zadaxin
Intervention Description
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.
Primary Outcome Measure Information:
Title
The liver transplantation-free survival rate of 90 days
Description
Survival condition of the patients were observed for 90 days
Time Frame
90 days
Secondary Outcome Measure Information:
Title
The liver transplantation-free survival rate of 180 days
Description
Survival condition of the patients were observed for 180 days
Time Frame
180 days
Title
Number of participants with ferver, bleeeding of injection site, amyotrophy and arthralgia
Description
Fever, bleeeding of injection site, amyotrophy and arthralgia were observed during the treatment in both group.
Time Frame
24 weeks
Title
Complications after 48 hours admission
Description
Occurence of encephalopathy, infection, bleeding,hepatorenal syndrome after 48 hours admission.
Time Frame
24 weeks
Title
Hepatitis B virus DNA load change
Description
Hepatitis B virus DNA were measured on week 0, 4,8,12 and 24 after the start of the infusion in both groups
Time Frame
24 weeks
Title
Causes of death/liver transplantation
Description
Causes of death/liver transplantation (e.g. liver failure, multiple organs failure, severe infection) were recorded in both groups.
Time Frame
24 weeks
Title
Inflammatory indexes change
Description
Inflammatory indexes were measured on week0,1,2, 4,8,12 and 24 after the start of the infusion in both groups
Time Frame
24 weeks
Title
Alanine aminotransferase change
Description
Levels of alanine aminotransferase were measured on week0,1,2, 4,8, 12 and 24 after the start of the infusion in both groups
Time Frame
24 weeks
Title
Glutamic oxaloacetic transaminase change
Description
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
Time Frame
24 weeks
Title
Total bilirubin change
Description
Levels of total bilirubin were measured on week0,1,2, 4,8,12 and 24 after the start of the infusion in both groups
Time Frame
24 weeks
Title
Plasma thrombin time change
Description
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
Time Frame
24 weeks
Title
Albumin time change
Description
Levels of albumin were measured on week0,1,2, 4,8, 12 and 24 after the start of the infusion in both groups
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin B Liang, MD
Organizational Affiliation
leading
Official's Role
Principal Investigator
Facility Information:
Facility Name
Third Affliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy and Safety of Thymosin-α1 in Patients With HBV-related ACLF
We'll reach out to this number within 24 hrs