Metadoxine as a Therapy for Severe Alcoholic Hepatitis

Severe Alcoholic Hepatitis Clinical Trial

Official title:

Impact of Metadoxine in the Oxidative Stress and Early Mortality in Patients With Severe Alcoholic Hepatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161653
• Other study ID #: DI/10/107/3/43
• Status: Completed
• Phase: Phase 4
• First received: June 10, 2014
• Last updated: November 8, 2014
• Start date: April 2010
• Est. completion date: September 2014

Study information

• Verified date: November 2014
• Source: Hospital General de Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis, Alcoholic
• Severe Alcoholic Hepatitis

Intervention

Drug:
• Prednisone plus Metadoxine

• Pentoxifylline plus Metadoxine

Locations

Country	Name	City	State
Mexico	Hospital General de Mexico	Mexico City	D.f.

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 day-survival		30 days	No
Primary	Malondialdehyde serum levels		14 and 30 days	No
Secondary	3 month-survival		3 months	No
Secondary	6 month-survival		6 months	No