Metadoxine as a Therapy for Severe Alcoholic Hepatitis
Phase 4
Completed
- Conditions
- Severe Alcoholic Hepatitis
- Interventions
- Registration Number
- NCT02161653
- Lead Sponsor
- Hospital General de Mexico
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 135
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pentoxifylline plus metadoxine Pentoxifylline plus Metadoxine Pentoxifylline 400 mg thrice in day by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days. Prednisone plus metadoxine Prednisone plus Metadoxine Prednisone 40 mg daily by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days.
- Primary Outcome Measures
Name Time Method 30 day-survival 30 days Malondialdehyde serum levels 14 and 30 days
- Secondary Outcome Measures
Name Time Method 3 month-survival 3 months 6 month-survival 6 months
Trial Locations
- Locations (1)
Hospital General de Mexico
🇲🇽Mexico City, D.f., Mexico