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Metadoxine as a Therapy for Severe Alcoholic Hepatitis

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ClinicalTrials.gov Identifier: NCT02161653
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : November 11, 2014
Sponsor:
Information provided by (Responsible Party):
MARIA DE FATIMA HIGUERA DE LA TIJERA, 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.

Condition or disease Intervention/treatment Phase
Severe Alcoholic Hepatitis Drug: Prednisone plus Metadoxine Drug: Pentoxifylline plus Metadoxine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Metadoxine in the Oxidative Stress and Early Mortality in Patients With Severe Alcoholic Hepatitis
Study Start Date : April 2010
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Prednisone plus Metadoxine
Experimental: Pentoxifylline plus metadoxine
Pentoxifylline 400 mg thrice in day by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days.
Drug: Pentoxifylline plus Metadoxine



Primary Outcome Measures :
  1. 30 day-survival [ Time Frame: 30 days ]
  2. Malondialdehyde serum levels [ Time Frame: 14 and 30 days ]

Secondary Outcome Measures :
  1. 3 month-survival [ Time Frame: 3 months ]
  2. 6 month-survival [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161653


Locations
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Mexico
Hospital General de Mexico
Mexico City, D.f., Mexico, 06726
Sponsors and Collaborators
Hospital General de Mexico
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: MARIA DE FATIMA HIGUERA DE LA TIJERA, MD, MSc., Hospital General de Mexico
ClinicalTrials.gov Identifier: NCT02161653    
Other Study ID Numbers: DI/10/107/3/43
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: November 11, 2014
Last Verified: November 2014
Keywords provided by MARIA DE FATIMA HIGUERA DE LA TIJERA, Hospital General de Mexico:
Severe alcoholic hepatitis
survival
oxidative stress
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Hepatitis, Alcoholic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Pyridoxine
Prednisone
Pentoxifylline
Metadoxine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors