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

• Status: Suspended
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital General de Mexico
• Treatments: Metadoxine; Pyridoxine

Criteria

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.