Overview

Treatment of Alcohol-Related Hepatitis With Arginine

Status:
Withdrawn
Trial end date:
2009-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
Collaborator:
Office of Dietary Supplements (ODS)
Criteria
Inclusion Criteria:

- Diagnosis of alcoholic hepatitis

- Maddrey's DF score less than 33

Exclusion Criteria:

- 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