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Completed

NCT Number: NCT02161653

Metadoxine as a Therapy for Severe Alcoholic Hepatitis

The purpose of this study is to determine whether metadoxine is effective for improve survival and reduced oxidative stress in patients with severe alcoholic hepatitis.

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Key information

Conditions

Severe Alcoholic Hepatitis Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Digestive System Diseases Hepatitis Hepatitis, Alcoholic Liver Diseases Liver Diseases, Alcoholic Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital General de Mexico

Mexico City, D.f., 06726, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with clinical and biochemical criteria for severe alcoholic hepatitis: Total bilirubin greater than 5 mg/dl in absence of biliary tract obstruction evidenced by ultrasound, history of chronic alcohol intake, leukocytosis, neutrophilia, elevation of transaminases with an aspartate aminotransferase / alanine aminotransferase ratio equal or greater than 2, discriminant function greater than 32.

Exclusion criteria

  • Diabetes, chronic kidney disease, hepatitis C, hepatitis B and or human immunodeficiency virus infection, asthma or history of atopy or allergic reactions, therapy in the previous two years with steroids, pentoxifylline, metadoxine, S-adenosyl L- methionine, antioxidants or multivitamins.

Treatment and study plan

Prednisone plus Metadoxine

Drug

Pentoxifylline plus Metadoxine

Drug

Primary outcomes

  1. 30 day-survival

    Time frame: 30 days

  2. Malondialdehyde serum levels

    Time frame: 14 and 30 days

Secondary outcomes

  1. 3 month-survival

    Time frame: 3 months

  2. 6 month-survival

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hospital General de Mexico

Other Gov

Registry information

Official study title

Impact of Metadoxine in the Oxidative Stress and Early Mortality in Patients With Severe Alcoholic Hepatitis

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jun 12, 2014
Registry last updated
Nov 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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