Clinical trial NCT03082885: 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
Overall status: COMPLETED
Phase: NA
Conditions: Liver Failure
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The liver transplantation-free survival rate of 90 days
timeFrame: 90 days
Secondary outcomes:
measure: The liver transplantation-free survival rate of 180 days
timeFrame: 180 days
measure: Number of participants with ferver, bleeeding of injection site, amyotrophy and arthralgia
timeFrame: 24 weeks
measure: Complications after 48 hours admission
timeFrame: 24 weeks
measure: Hepatitis B virus DNA load change
timeFrame: 24 weeks
measure: Causes of death/liver transplantation
timeFrame: 24 weeks
measure: Inflammatory indexes change
timeFrame: 24 weeks
measure: Alanine aminotransferase change
timeFrame: 24 weeks
measure: Glutamic oxaloacetic transaminase change
timeFrame: 24 weeks
measure: Total bilirubin change
timeFrame: 24 weeks
measure: Plasma thrombin time change
timeFrame: 24 weeks
measure: Albumin time change
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Third Affliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: leading
name: Lin B Liang, MD
role: PRINCIPAL_INVESTIGATOR
References: