Efficacy Study of Anakinra, Pentoxifylline, and Zinc Compared to Methylprednisolone in Severe Acute Alcoholic Hepatitis

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.

Conditions

• Acute Alcoholic Hepatitis

Interventions

DRUG

Anakinra

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

DRUG

Pentoxifylline

Pentoxifylline, generic

DRUG

Zinc Sulfate

Zinc Sulfate, nutritional supplement

DRUG

Methylprednisolone

Methylprednisolone, corticosteroid

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• The Cleveland Clinic

  collaborator OTHER

• University of Massachusetts, Worcester

  collaborator OTHER

• University of Louisville

  collaborator OTHER

• Mack Mitchell

  lead OTHER

Principal Investigators

• Mack C Mitchell, MD · University of Texas Southwestern Medical Center

• Arthur J McCullough, MD · The Cleveland Clinic

• Craig J McClain, MD · University of Louisville

• Gyongi Szabo, MD · University of Massachusetts, Worcester

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-09-30

Primary Completion

2018-10-31

Completion

2018-10-31

Countries

• United States

Study Locations