Back to resultsMetadoxine as a Therapy for Severe Alcoholic Hepatitis
Primary Purpose
Severe Alcoholic Hepatitis
Status
Completed
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
Prednisone plus Metadoxine
Pentoxifylline plus Metadoxine
Sponsored by
About this trial
This is an interventional treatment trial for Severe Alcoholic Hepatitis focused on measuring Severe alcoholic hepatitis, survival, oxidative stress
Eligibility Criteria
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.
Sites / Locations
- Hospital General de Mexico
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
No Intervention
Experimental
Experimental
Arm Label
Prednisone
Pentoxifylline
Prednisone plus metadoxine
Pentoxifylline plus metadoxine
Arm Description
Prednisone 40 mg daily by mouth during 30 days.
Pentoxifylline 400 mg thrice in day by mouth during 30 days
Prednisone 40 mg daily by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days.
Pentoxifylline 400 mg thrice in day by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days.
Outcomes
Primary Outcome Measures
30 day-survival
Malondialdehyde serum levels
Secondary Outcome Measures
3 month-survival
6 month-survival
Full Information
NCT ID
NCT02161653
First Posted
June 10, 2014
Last Updated
November 8, 2014
Sponsor
Hospital General de Mexico
1. Study Identification
Unique Protocol Identification Number
NCT02161653
Brief Title
Metadoxine as a Therapy for Severe Alcoholic Hepatitis
Official Title
Impact of Metadoxine in the Oxidative Stress and Early Mortality in Patients With Severe Alcoholic Hepatitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General de Mexico
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Alcoholic Hepatitis
Keywords
Severe alcoholic hepatitis, survival, oxidative stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prednisone
Arm Type
No Intervention
Arm Description
Prednisone 40 mg daily by mouth during 30 days.
Arm Title
Pentoxifylline
Arm Type
No Intervention
Arm Description
Pentoxifylline 400 mg thrice in day by mouth during 30 days
Arm Title
Prednisone plus metadoxine
Arm Type
Experimental
Arm Description
Prednisone 40 mg daily by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days.
Arm Title
Pentoxifylline plus metadoxine
Arm Type
Experimental
Arm Description
Pentoxifylline 400 mg thrice in day by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days.
Intervention Type
Drug
Intervention Name(s)
Prednisone plus Metadoxine
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline plus Metadoxine
Primary Outcome Measure Information:
Title
30 day-survival
Time Frame
30 days
Title
Malondialdehyde serum levels
Time Frame
14 and 30 days
Secondary Outcome Measure Information:
Title
3 month-survival
Time Frame
3 months
Title
6 month-survival
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital General de Mexico
City
Mexico City
State/Province
D.f.
ZIP/Postal Code
06726
Country
Mexico
12. IPD Sharing Statement
Citations:
PubMed Identifier
25945012
Citation
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.
Results Reference
derived
Learn more about this trial
Metadoxine as a Therapy for Severe Alcoholic Hepatitis
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