Metadoxine as a Therapy for Severe Alcoholic Hepatitis

Hospital General de Mexico

Status and phase: Completed; Phase 4

Conditions: Severe Alcoholic Hepatitis

Treatments: Drug: Pentoxifylline plus Metadoxine; Drug: Prednisone plus Metadoxine

Study type: Interventional

Funder types: Other

Identifiers

NCT02161653

DI/10/107/3/43

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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135 participants in 4 patient groups

Prednisone

No Intervention group

Description:

Prednisone 40 mg daily by mouth during 30 days.

Pentoxifylline

No Intervention group

Description:

Pentoxifylline 400 mg thrice in day by mouth during 30 days

Prednisone plus metadoxine

Experimental group

Description:

Prednisone 40 mg daily by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days.

Treatment:

Drug: Prednisone plus Metadoxine

Pentoxifylline plus metadoxine

Experimental group

Description:

Pentoxifylline 400 mg thrice in day by mouth plus Metadoxine 500 mg thrice in day by mouth during 30 days.

Treatment:

Drug: Pentoxifylline plus Metadoxine