Loading clinical trials...

Metadoxine as a Therapy for Severe Alcoholic Hepatitis | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Metadoxine as a Therapy for Severe Alcoholic Hepatitis

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

NCT02161653•Hospital General de Mexico

Summary

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Hospital General de Mexico

Mexico City, D.f., Mexico

Key Dates

Start Date

April 1, 2010

Primary Completion Date

September 1, 2014

Completion Date

September 1, 2014

Last Updated

November 11, 2014

Enrollment

135

ACTUAL participants

Conditions

Severe Alcoholic Hepatitis

Interventions

Prednisone plus Metadoxine

DRUG

Pentoxifylline plus Metadoxine

DRUG

Role of Extended Low Dose Prednisolone in Achieving Clinical and Biochemical Remission in Steroid Responsive Severe Alcoholic Hepatitis

NCT06155760

Severe Alcoholic Hepatitis

View study

UNKNOWN

Invasive Fungal Infections in Severe Alcohol-associated Hepatitis

NCT04103840

Severe Alcoholic HepatitisChronic Liver Disease and Cirrhosis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 11, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Metadoxine as a Therapy for Severe Alcoholic Hepatitis

Inclusion Criteria

Exclusion Criteria

Role of Extended Low Dose Prednisolone in Achieving Clinical and Biochemical Remission in Steroid Responsive Severe Alcoholic Hepatitis

Invasive Fungal Infections in Severe Alcohol-associated Hepatitis

Assessment of the Predictive Value of Fecal Calprotectin for the Outcome of Severe Alcoholic Hepatitis

Efficacy of G-CSF in the Management of Steroid Non-responsive Severe Alcoholic Hepatitis