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Metadoxine as a Therapy for Severe Alcoholic Hepatitis

NCT ID: NCT02161653

Last Updated: 2014-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Severe Alcoholic Hepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prednisone

Prednisone 40 mg daily by mouth during 30 days.

Group Type NO_INTERVENTION

No interventions assigned to this group

Pentoxifylline

Pentoxifylline 400 mg thrice in day by mouth during 30 days

Group Type NO_INTERVENTION

No interventions assigned to this group

Prednisone plus metadoxine

Prednisone 40 mg daily by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days.

Group Type EXPERIMENTAL

Prednisone plus Metadoxine

Intervention Type DRUG

Pentoxifylline plus metadoxine

Pentoxifylline 400 mg thrice in day by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days.

Group Type EXPERIMENTAL

Pentoxifylline plus Metadoxine

Intervention Type DRUG

Interventions

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Prednisone plus Metadoxine

Intervention Type DRUG

Pentoxifylline plus Metadoxine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General de Mexico

OTHER_GOV

Sponsor Role lead

Responsible Party

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MARIA DE FATIMA HIGUERA DE LA TIJERA

MD, MSc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital General de Mexico

Mexico City, D.f., Mexico

Site Status

Countries

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Mexico

References

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Higuera-de la Tijera F, Servin-Caamano AI, Serralde-Zuniga AE, Cruz-Herrera J, Perez-Torres E, Abdo-Francis JM, Salas-Gordillo F, Perez-Hernandez JL. Metadoxine improves the three- and six-month survival rates in patients with severe alcoholic hepatitis. World J Gastroenterol. 2015 Apr 28;21(16):4975-85. doi: 10.3748/wjg.v21.i16.4975.

Reference Type DERIVED
PMID: 25945012 (View on PubMed)

Other Identifiers

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DI/10/107/3/43

Identifier Type: -

Identifier Source: org_study_id