Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis
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.
Timeline
- Start
- 2020-07-10
- Primary completion
- 2022-05-24
- Completion
- 2022-08-12
Publications
- Gawrieh S, Dasarathy S, Tu W, Kamath PS, Chalasani NP, McClain CJ, Bataller R, Szabo G, Tang Q, Radaeva S, Barton B, Nagy LE, Shah VH, Sanyal AJ, Mitchell MC; AlcHepNet Investigators. Randomized trial of anakinra plus zinc vs. prednisone for severe alcohol-associated hepatitis. J Hepatol. 2024 May;80(5):684-693. doi: 10.1016/j.jhep.2024.01.031. Epub 2024 Feb 10.
- Dasarathy S, Tu W, Bellar A, Welch N, Kettler C, Tang Q, Liangpunsakul S, Gawrieh S, Radaeva S, Mitchell M; AlcHepNet. Development and evaluation of objective trial performance metrics for multisite clinical studies: Experience from the AlcHep Network. Contemp Clin Trials. 2024 Mar;138:107437. doi: 10.1016/j.cct.2024.107437. Epub 2024 Jan 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Anakinra | Protein / enzyme biologic | 100 mg | Subcutaneous |
| Comparator | Prednisone | Other / unclassified | 40 mg | Oral |
| Comparator | Zinc Sulfate | Unknown | 220 mg | Oral |