NCT00200746

Brief Summary

The purpose of this study is to test the effectiveness of the amino acid arginine in reducing liver injury in individuals with alcohol-related hepatitis.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

March 12, 2013

Status Verified

March 1, 2013

Enrollment Period

3.3 years

First QC Date

September 12, 2005

Last Update Submit

March 11, 2013

Conditions

Alcoholic Hepatitis

Keywords

HepatitisLiver DiseasesAlcoholismArginine

Outcome Measures

Primary Outcomes (2)

  • Percent reduction in liver endotoxin production

    After nutritional intervention

  • change in Maddrey's discriminant function (DF) score

    After nutritional intervention

Study Arms (3)

2

EXPERIMENTAL

Moderate Arginine

Drug: Arginine

3

SHAM COMPARATOR

Polycose control arm

Drug: Arginine

1

EXPERIMENTAL

High Arginine

Drug: Arginine

Interventions

ArginineDRUG

Amino Acid Arginine

123

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of alcoholic hepatitis
  • Maddrey's DF score less than 33

You may not qualify if:

  • Hepatitis C or B virus infected
  • HIV infected
  • History of cancer
  • Hepatic encephalopathy (a condition in which liver failure affects the central nervous system)
  • Kidney failure
  • A Do Not Resuscitate order (a patient-directed order not to resuscitate in the event that resuscitation is necessary to prevent death)
  • Maddrey's DF score of 33 or greater after vitamin K administration during the study
  • Alcohol withdrawal at study entry
  • Active pneumonia at study entry
  • Allergy to iodine
  • Enrollment in any other clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harbor - University of California Los Angeles Medical Center

Torrance, California, 90509, United States

Location

MeSH Terms

Conditions

Hepatitis, AlcoholicHepatitisLiver DiseasesAlcoholism

Interventions

Arginine

Condition Hierarchy (Ancestors)

Digestive System DiseasesLiver Diseases, AlcoholicAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Essential

Study Officials

  • John A. Tayek, MD

    Los Angeles Biomedical Research Institute at Harbor - University of Los Angeles Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

April 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

March 12, 2013

Record last verified: 2013-03

Locations

US(1)