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Interleukin-1 (IL-1) Receptor Antagonist

Anakinra and Zinc for Alcoholic Hepatitis (AlcHepNet Trial)

Phase 2
Waitlist Available
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7, 30, and 90 days
Awards & highlights

AlcHepNet Trial Summary

This trial is testing a new treatment for severe alcoholic hepatitis, which is a life-threatening stage of alcoholic liver injury. The new treatment consists of Anakinra (plus zinc) and is being compared to the current standard medical treatment of prednisone. The trial's objectives are to determine the clinical efficacy and safety of Anakinra, to evaluate the use of biomarkers to assess disease severity and treatment response, and to develop novel endpoints to overcome the limitations of current assessment strategies for severe AH.

Eligible Conditions
  • Alcoholic Hepatitis

AlcHepNet Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

AlcHepNet Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7, 30, and 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7, 30, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Survival at 90 Days
Secondary outcome measures
Changes in Liver Function
Changes in MELD Score
Development of Multi-organ Failure
+12 more

AlcHepNet Trial Design

2Treatment groups
Active Control
Group I: Anakinra and ZincActive Control2 Interventions
Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30).
Group II: PrednisoneActive Control2 Interventions
Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90).

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
977 Previous Clinical Trials
983,166 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
796 Previous Clinical Trials
1,361,276 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~31 spots leftby Mar 2025