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

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

Sponsors

Lead Sponsor: Hospital General de Mexico

Source Hospital General de Mexico
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.

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.

Overall Status Suspended
Start Date 2015-08-01
Completion Date 2021-08-01
Primary Completion Date 2021-08-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
improvement in the degree of non-alcoholic fatty liver disease score (NAS) 6 months
Secondary Outcome
Measure Time Frame
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
improvement in the degree of liver fibrosis measured on a scale from 0 to 2 6 months
to compare the occurrence of adverse effects between groups 6 months
Enrollment 108
Condition
Intervention

Intervention Type: Drug

Intervention Name: metadoxine

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

Arm Group Label: Group 2: Metadoxine

Other Name: Abrixone, Metadoxil

Intervention Type: Other

Intervention Name: placebo

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

Arm Group Label: Group 1: Placebo

Eligibility

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Fatima Higuera-de la Tijera, MD, MSc. Study Director Hospital General de México
Location
Facility: Hospital General de México
Location Countries

Mexico

Verification Date

2020-02-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Hospital General de Mexico

Investigator Full Name: MARIA DE FATIMA HIGUERA DE LA TIJERA

Investigator Title: MD, MSc.

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Group 1: Placebo

Type: Placebo Comparator

Description: Placebo

Label: Group 2: Metadoxine

Type: Experimental

Description: therapy with metadoxine

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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