The Efficacy and Safety of Thymosin-α1 in Patients With HBV-related ACLF (NCT03082885) | Clinical Trial Compass
CompletedNot Applicable
The Efficacy and Safety of Thymosin-α1 in Patients With HBV-related ACLF
China120 participantsStarted 2017-04-10
Plain-language summary
A randomized controlled trial to evaluate efficacy and safety of Thymosin-α1 administration in patients with HBV-related Acute-on-chronic liver failure.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.Pa…
What they're measuring
1
The liver transplantation-free survival rate of 90 days