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

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ClinicalTrials.gov Identifier: NCT02541045
Recruitment Status : Suspended (lack of resources to finance the project)
First Posted : September 4, 2015
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
MARIA DE FATIMA HIGUERA DE LA TIJERA, 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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Steatohepatitis Drug: metadoxine Other: placebo Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial to Evaluate the Efficacy of Metadoxine as a Therapy for Patients With Non-alcoholic Steatohepatitis
Actual Study Start Date : August 2015
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019


Arm Intervention/treatment
Placebo Comparator: Group 1: Placebo
Placebo
Other: placebo
placebo tablets: 1 Tablet by mouth twice in day during 6 months

Experimental: Group 2: Metadoxine
therapy with metadoxine
Drug: metadoxine
metadoxine 500mg tablets: 1 Tablet by mouth twice in day during 6 months
Other Name: Abrixone, Metadoxil




Primary Outcome Measures :
  1. improvement in the degree of non-alcoholic fatty liver disease score (NAS) [ Time Frame: 6 months ]
    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


Secondary Outcome Measures :
  1. improvement in liver steatosis measured on a scale from 0 to 3 [ Time Frame: 6 months ]
    Liver biopsy: measured on a scale from 0 to 3

  2. improvement in lobular inflammation measured on a scale from 0 to 3 [ Time Frame: 6 months ]
    Liver biopsy: measured on a scale from 0 to 3

  3. improvement in ballooning measured on a scale from 0 to 2 [ Time Frame: 6 months ]
    Liver biopsy: measured on a scale from 0 to 2

  4. improvement in alanine aminotransferase serum levels [ Time Frame: 6 months ]
  5. improvement in aspartate aminotransferase serum levels [ Time Frame: 6 months ]
  6. improvement in the degree of liver fibrosis measured on a scale from 0 to 2 [ Time Frame: 6 months ]
    Liver biopsy: measured on a scale from 0 to 2

  7. to compare the occurrence of adverse effects between groups [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541045


Locations
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Mexico
Hospital General de México
Mexico City, DF, Mexico, 06726
Sponsors and Collaborators
Hospital General de Mexico
Investigators
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Study Director: Fatima Higuera-de la Tijera, MD, MSc. Hospital General de México

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Responsible Party: MARIA DE FATIMA HIGUERA DE LA TIJERA, MD, MSc., Hospital General de Mexico
ClinicalTrials.gov Identifier: NCT02541045     History of Changes
Other Study ID Numbers: DI/15/108/03/48
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018

Keywords provided by MARIA DE FATIMA HIGUERA DE LA TIJERA, Hospital General de Mexico:
non-alcoholic steatohepatitis
metadoxine
efficacy
therapy

Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Metadoxine
Pyridoxine
Alcohol Deterrents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs