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.
The Efficacy and Safety of Thymosin-α1 in Patients With HBV-related ACLF
Status
Completed
Phase
Not applicable
Enrollment
120
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
A randomized controlled trial to evaluate efficacy and safety of Thymosin-α1 administration in patients with HBV-related Acute-on-chronic liver failure.
Full 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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Mar 17, 2017
Study start
Apr 10, 2017
Primary completion
Jun 2, 2019
Study completion
Jul 30, 2019
Results posted
Not reported
Registry updated
Aug 16, 2021
Outcomes
What the study measures.
Primary outcomes
The liver transplantation-free survival rate of 90 days
Time frame · 90 days
Survival condition of the patients were observed for 90 days
Secondary outcomes
The liver transplantation-free survival rate of 180 days
Time frame · 180 days
Survival condition of the patients were observed for 180 days
Number of participants with ferver, bleeeding of injection site, amyotrophy and arthralgia
Time frame · 24 weeks
Fever, bleeeding of injection site, amyotrophy and arthralgia were observed during the treatment in both group.
Complications after 48 hours admission
Time frame · 24 weeks
Occurence of encephalopathy, infection, bleeding,hepatorenal syndrome after 48 hours admission.
Hepatitis B virus DNA load change
Time frame · 24 weeks
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
Time frame · 24 weeks
Causes of death/liver transplantation (e.g. liver failure, multiple organs failure, severe infection) were recorded in both groups.
Inflammatory indexes change
Time frame · 24 weeks
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
Time frame · 24 weeks
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
Time frame · 24 weeks
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
Time frame · 24 weeks
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
Time frame · 24 weeks
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
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Sex
- ALL
- Healthy volunteers
- No
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 locations
1 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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More studies on Thymosin Alpha-1.
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TPF Concurrent Chemo-radiotherapy Plus Immunotherapy for Local Advanced Esophageal Squamous Cell Carcinoma
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Not applicable
Active, not recruiting
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Phase II Trial of Neoadjuvant Thymalfasin, PD-1 Inhibitor, and Chemoradiotherapy for cStage III GEJ Adenocarcinoma
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