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

NCT02541045 | Withdrawn Phase 3 DMC

• 1 other identifier: DI/15/108/03/48
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-alcoholic Steatohepatitis

Keywords

non-alcoholic steatohepatitis; metadoxine; efficacy; therapy

Outcome Measures

Primary Outcomes (1)

• improvement in the degree of non-alcoholic fatty liver disease score (NAS)

  Non-alcoholic fatty liver disease score (NAS) is an histological classification to assessed the severity of liver steatosis, lobular inflammation and ballooning in the liver biopsy. It is measured on a scale from 0 to 8

  6 months

Secondary Outcomes (7)

• improvement in liver steatosis measured on a scale from 0 to 3

  6 months

• improvement in lobular inflammation measured on a scale from 0 to 3

  6 months

• improvement in ballooning measured on a scale from 0 to 2

  6 months

• improvement in alanine aminotransferase serum levels

  6 months

• improvement in aspartate aminotransferase serum levels

  6 months

Study Arms (2)

Group 1: Placebo

PLACEBO COMPARATOR

Placebo

Other: placebo

Group 2: Metadoxine

EXPERIMENTAL

therapy with metadoxine

Drug: metadoxine

Interventions

metadoxine DRUG

metadoxine 500mg tablets: 1 Tablet by mouth twice in day during 6 months

Also known as: Abrixone, Metadoxil

Group 2: Metadoxine

placebo OTHER

placebo tablets: 1 Tablet by mouth twice in day during 6 months

Group 1: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital General de Mexico: lead

Study Sites (1)

Hospital General de México

Mexico City, Mexico City, 06726, Mexico

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

metadoxine

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Fatima Higuera-de la Tijera, MD, MSc.

  Hospital General de México

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc.

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 4, 2015
• Study Start: August 1, 2015
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

ME (1)