Liver Failure
Conditions
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.
Interventions
DRUGThymosin-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.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The liver transplantation-free survival rate of 90 days | 90 days | Survival condition of the patients were observed for 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| The liver transplantation-free survival rate of 180 days | 180 days | Survival condition of the patients were observed for 180 days |
| 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 |
| 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 |
Countries
China
Outcome results
None listed