The Efficacy and Safety of Thymosin-α1 in Patients With HBV-related ACLF
- Conditions
- Liver Failure
- Interventions
- Drug: Thymosin-α1
- Registration Number
- NCT03082885
- Lead Sponsor
- Sun Yat-sen University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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.
-
- Willing to provide informed consent and comply with the test requirements
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Thymosin-α1 group Thymosin-α1 Patients receive treatment based on standard Therapy with additional Thymosin-α1
- Primary Outcome Measures
Name Time Method The liver transplantation-free survival rate of 90 days 90 days Survival condition of the patients were observed for 90 days
- Secondary Outcome Measures
Name Time Method The liver transplantation-free survival rate of 180 days 180 days Survival condition of the patients were observed for 180 days
Number of participants with ferver, bleeeding of injection site, amyotrophy and arthralgia 24 weeks Fever, bleeeding of injection site, amyotrophy and arthralgia were observed during the treatment in both group.
Complications after 48 hours admission 24 weeks Occurence of encephalopathy, infection, bleeding,hepatorenal syndrome after 48 hours admission.
Hepatitis B virus DNA load change 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 24 weeks Causes of death/liver transplantation (e.g. liver failure, multiple organs failure, severe infection) were recorded in both groups.
Inflammatory indexes change 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 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 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 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 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
Albumin time change 24 weeks Levels of albumin were measured on week0,1,2, 4,8, 12 and 24 after the start of the infusion in both groups
Trial Locations
- Locations (1)
Third Affliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Third Affliated Hospital of Sun Yat-sen University🇨🇳Guangzhou, Guangdong, China