CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 104 enrolled
Drug / intervention
Anakinra +3 moredrug
Likely dose
Anakinra 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01809132
NCT01809132Phase 3Completed
CompareCT.gov

Double-blind Randomized Controlled Trial of Anakinra, Pentoxifylline, and Zinc Compared to Methylprednisolone in Severe Acute Alcoholic Hepatitis

Mack Mitchell·interventional·Posted Mar 12, 2013·Updated Nov 1, 2021

In Brief

A Phase 3 clinical trial evaluating Anakinra, Pentoxifylline, and 2 other interventions for Acute Alcoholic Hepatitis. Completed, enrolled 104 participants across 4 sites.

Detailed Summary

This study will compare two different treatments of acute alcoholic hepatitis. The current standard of care is treatment with corticosteroids (methylprednisolone). This will be compared to treatment with anakinra, pentoxifylline, plus zinc sulfate. The participants will be treated and followed for 6 months and the two treatment groups will be compared for differences in death rates and laboratory tests that measure liver and gut function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Alcoholic Hepatitis
CountriesUnited States
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA), The Cleveland Clinic, University of Massachusetts, Worcester, University of Louisville

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 12, 2013
Enrollment StartSep 1, 2013
Primary CompletionOct 1, 2018
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 13.3 years ago

Interventions

Anakinradrug

Anakinra, interleukin-1 receptor antagonist; 100 mg/0.67 mL solution for subcutaneous injection.

Pentoxifyllinedrug

Pentoxifylline, generic

Zinc Sulfatedrug

Zinc Sulfate, nutritional supplement

Methylprednisolonedrug

Methylprednisolone, corticosteroid