Clinical Trial to Evaluate the Efficacy of Metadoxine as a Therapy for Patients With Non-alcoholic Steatohepatitis

DI/15/108/03/48

The aim of this study is to evaluate the efficacy of metadoxine as a therapy for patients with biopsy-proven non-alcoholic steatohepatitis.

2015-08-01

2024-03-01

2024-03-01

Withdrawn

Early phase I

Inclusion Criteria: * Non-diabetic patients, * Overweight or with obesity degrees I, II or III according to WHO criteria (BMI ≥ 25), * With evidence of liver steatosis in the ultrasonography, * With biopsy-proven nonalcoholic steatohepatitis, with ≥ 3 in the NAS score (at least 1 point for liver steatosis, at least 1 point for lobular inflammation, and at least 1 point for ballooning), * With or without fibrosis in the liver biopsy, but if it is present must be ≤ 2 on a scale of 4, where 4 is equivalent to cirrhosis. Exclusion Criteria: * Cirrhosis, * Diabetes, * Heavy alcohol intake ( ≥ 20 g / day), ≥ 8 points in the "Alcohol Use Disorders Identification Test" (AUDIT), * Acute or chronic hepatitis C, * Acute or chronic hepatitis B, * Immunodeficiency acquired syndrome * Pregnant women, * In the last year, history of herbal consumption, total parenteral nutrition, amiodarone, methotrexate, hormonal contraceptives, steroids, tamoxifen, valproic acid or any other drug associated with the development of liver steatosis. * Uncontrolled hypothyroidism or hyperthyroidism, * Any uncontrolled chronic disease.

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2024-03-15