Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis (NCT04072822) | Clinical Trial Compass
CompletedPhase 2
Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis
United States147 participantsStarted 2020-07-10
Plain-language summary
This multicenter, randomized, double blinded, placebo-controlled clinical trial is focused on novel treatments for severe alcoholic hepatitis (AH), a life-threatening stage of alcoholic liver injury that has a short-term mortality rate much higher than that of other liver diseases.
The primary objective of the study is to determine the clinical efficacy and safety of Anakinra (plus zinc) compared to the current standard medical treatment consisting of prednisone in participants with clinically severe AH. Key secondary objectives broadly are as follows: (a) to evaluate the use of biomarkers to assess disease severity and treatment response; and (b) to develop novel endpoints to overcome the limitations of current assessment strategies for severe AH.
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. AH, as defined by the NIAAA pan-consortia for AH:
✓. Onset of jaundice (defined as serum total bilirubin \>3 mg/dL) within the prior 8 weeks to screening visit
✓. Regular consumption of alcohol with an intake of \> 40 gm daily or \>280gm weekly on average for women and \> 60 gm daily or \>420gm weekly on average for men for 6 months or more, with less than 8 weeks of abstinence before onset of jaundice
✓. AST \> 50 IU/l
✓. AST:ALT \> 1.5 and both values \< 400 IU/l
✓. and/or histological evidence of AH\*
✓. MELD 20-35 on day of randomization.
✓. Ages \>21
Exclusion criteria
✕. MELD SCORE \<20 or \> 35
✕. Active sepsis (positive blood or ascitic cultures) with Systemic Inflammatory Response Syndrome (SIRS) or hemodynamic compromise requiring intravenous pressors to maintain tissue perfusion
✕. Renal failure defined by GFR \<35 mL/min by CKD-EPI.
✕. Clinically active C. diff infection
✕. History of imaging of the liver (ultrasound, computerized tomography or magnetic resonance) showing other causes of jaundice
✕. History of other liver diseases including hepatitis B (positive HBsAg or HBV DNA), hepatitis C (positive HCV RNA), autoimmune hepatitis, Wilson disease, genetic \\hemochromatosis, alpha1-antitrypsin deficiency or strong suspicion of Drug Induced Liver Injury (DILI). Previously treated hepatitis C that was cured (sustained virological response with negative RNA ≥24 weeks following treatment) is not an exclusion.