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NCT01809132 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Acute Alcoholic Hepatitis, sponsored by Mack Mitchell.

Completed
Registry status
Phase 2
Development phase
104
Enrollment target
4
Study locations

NCT01809132 is a Phase 2 study of Acute Alcoholic Hepatitis that has completed, run by Mack Mitchell. The registered enrollment target is 104 participants. The trial reports 4 study locations across 4 states.

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The verdict

NCT01809132, a Phase 2 study of Acute Alcoholic Hepatitis, has completed, sponsored by Mack Mitchell.

COMPLETED
Registry status
Phase 2
Development phase
104 participants
Enrollment target
4
Study locations

Study 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 Studied

Interventions

  • DRUG Pentoxifylline
  • DRUG Methylprednisolone
  • DRUG Anakinra
  • DRUG Zinc Sulfate

Study Locations (4)

Kentucky

  • University of Louisville - Louisville

Massachusetts

  • University of Massachusetts Medical School - Worcester

Ohio

  • Cleveland Clinic - Cleveland

Texas

  • University of Texas Southwestern Medical Center - Dallas

Trial Details

FieldValue
Enrollment Target 104 participants
Start Date 2013-09
Est. Completion 2018-10
Phase Phase 2

Sponsor

Mack Mitchell

1 total trials

What the Registry Record Tells You About NCT01809132

The ClinicalTrials.gov registry entry for NCT01809132 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mack Mitchell, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Acute Alcoholic Hepatitis appearing as the primary indexed condition, and to 4 interventions - of which Pentoxifylline is the first listed.

NCT01809132 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Kentucky, Massachusetts, Ohio.

Frequently Asked Questions

What is clinical trial NCT01809132 about?

NCT01809132 is a clinical study titled "Efficacy Study of Anakinra, Pentoxifylline, and Zinc Compared to Methylprednisolone in Severe Acute Alcoholic Hepatitis". 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...

What is the current status of trial NCT01809132?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2013-09. Estimated completion is 2018-10.

What conditions does trial NCT01809132 study?

This clinical trial studies the following conditions: Acute Alcoholic Hepatitis.

What interventions are being tested in trial NCT01809132?

The interventions under investigation include: Pentoxifylline (DRUG), Methylprednisolone (DRUG), Anakinra (DRUG), Zinc Sulfate (DRUG).

Who is sponsoring clinical trial NCT01809132?

This trial is sponsored by Mack Mitchell, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01809132 being conducted?

This trial has 4 study locations across Kentucky, Massachusetts, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.