NCT02541045

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hospital General de Mexico · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Type and design of the study: A randomized, placebo-controlled, double-blind, clinical trial to evaluate the efficacy of metadoxine as a therapy in patients with biopsy-proven nonalcoholic steatohepatitis. Population: Non-diabetic patients with nonalcoholic steatohepatitis diagnosed by liver biopsy through the "nonalcoholic fatty liver disease activity score" (NAS)\> 3. Sample size: Considering a difference of at least 30% between groups, a confidence level of 95% (two-sided, significance 0.05), a statistical power of 80%, and an additional 20% for possible losses, we need 54 patients per group. Variables: Independent: Treatment group (metadoxine / placebo). Dependents: * "Nonalcoholic fatty liver disease activity score" (NAS):0 a 8 * Degree of liver steatosis: 0 a 3 * Degree of lobular inflammation: 0 a 3 * Degree of ballooning: 0 a 2 * Degree of fibrosis: 0 a 2 * Weight: Kg * Body mass index: Kg/m2 * Waist circumference: cm * Serum alanine aminotransferase: U/L * Serum aspartate aminotransferase: U/L Methods: Those meeting the selection criteria will be invited to participate in this study, those who agree to participate must sign the consent form and will be randomized to placebo or metadoxine group. The duration of the therapy will be 6 months and after this period a second liver biopsy will be performed to assessed the improvement on liver histology.

Conditions

• Non-alcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	metadoxine	metadoxine 500mg tablets: 1 Tablet by mouth twice in day during 6 months
OTHER	placebo	placebo tablets: 1 Tablet by mouth twice in day during 6 months

Timeline

• Start date: 2015-08-01
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2015-09-04
• Last updated: 2024-03-15

Locations

1 site across 1 country: Mexico