Metadoxine as a Therapy for Severe Alcoholic Hepatitis
Overview
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.
Full Title of Study: “Impact of Metadoxine in the Oxidative Stress and Early Mortality in Patients With Severe Alcoholic Hepatitis”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: September 2014
Interventions
- Drug: Prednisone plus Metadoxine
- Drug: Pentoxifylline plus Metadoxine
Arms, Groups and Cohorts
- No Intervention: Prednisone
- Prednisone 40 mg daily by mouth during 30 days.
- No Intervention: Pentoxifylline
- Pentoxifylline 400 mg thrice in day by mouth during 30 days
- Experimental: Prednisone plus metadoxine
- Prednisone 40 mg daily by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days.
- Experimental: Pentoxifylline plus metadoxine
- Pentoxifylline 400 mg thrice in day by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days.
Clinical Trial Outcome Measures
Primary Measures
- 30 day-survival
- Time Frame: 30 days
- Malondialdehyde serum levels
- Time Frame: 14 and 30 days
Secondary Measures
- 3 month-survival
- Time Frame: 3 months
- 6 month-survival
- Time Frame: 6 months
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Hospital General de Mexico
- Provider of Information About this Clinical Study
- Principal Investigator: MARIA DE FATIMA HIGUERA DE LA TIJERA, MD, MSc. – Hospital General de Mexico
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