Metadoxine as a Therapy for Severe Alcoholic Hepatitis
Impact of Metadoxine in the Oxidative Stress and Early Mortality in Patients With Severe Alcoholic Hepatitis
1 other identifier
interventional
135
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2010
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 10, 2014
CompletedFirst Posted
Study publicly available on registry
June 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedNovember 11, 2014
November 1, 2014
4.4 years
June 10, 2014
November 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
30 day-survival
30 days
Malondialdehyde serum levels
14 and 30 days
Secondary Outcomes (2)
3 month-survival
3 months
6 month-survival
6 months
Study Arms (4)
Prednisone
NO INTERVENTIONPrednisone 40 mg daily by mouth during 30 days.
Pentoxifylline
NO INTERVENTIONPentoxifylline 400 mg thrice in day by mouth during 30 days
Prednisone plus metadoxine
EXPERIMENTALPrednisone 40 mg daily by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days.
Pentoxifylline plus metadoxine
EXPERIMENTALPentoxifylline 400 mg thrice in day by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital General de Mexico
Mexico City, D.f., 06726, Mexico
Related Publications (1)
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.
PMID: 25945012DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, MSc.
Study Record Dates
First Submitted
June 10, 2014
First Posted
June 12, 2014
Study Start
April 1, 2010
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
November 11, 2014
Record last verified: 2014-11