Non-alcoholic SteatohepatitisPhase 3NCT02541045
Clinical Trial to Evaluate the Efficacy of Metadoxine as a Therapy for Patients With Non-alcoholic Steatohepatitis
A Phase 3 study testing metadoxine in people with Non-alcoholic Steatohepatitis, run by Hospital General de Mexico at 1 site in Mexico.
Trial summary
The aim of this study is to evaluate the efficacy of metadoxine as a therapy for patients with biopsy-proven non-alcoholic steatohepatitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-alcoholic Steatohepatitis
- What is being tested?
- metadoxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2015to Mar 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the efficacy of metadoxine as a therapy for patients with biopsy-proven non-alcoholic steatohepatitis.
Read the 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
- Being tested
- metadoxine, placebo
- Keywords
- non-alcoholic steatohepatitis, metadoxine, efficacy, therapy
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metadoxineDrug
Also called Abrixone, Metadoxil
metadoxine 500mg tablets: 1 Tablet by mouth twice in day during 6 months
placeboOther
placebo tablets: 1 Tablet by mouth twice in day during 6 months
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Placebo | Placebo comparator | Placebo Receives: Other: placebo |
| Group 2: Metadoxine | Experimental | therapy with metadoxine Receives: Drug: metadoxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (7)
improvement in liver steatosis measured on a scale from 0 to 3
Liver biopsy: measured on a scale from 0 to 3
Measured: 6 months
improvement in lobular inflammation measured on a scale from 0 to 3
Liver biopsy: measured on a scale from 0 to 3
Measured: 6 months
improvement in ballooning measured on a scale from 0 to 2
Liver biopsy: measured on a scale from 0 to 2
Measured: 6 months
improvement in alanine aminotransferase serum levels
Measured: 6 months
improvement in aspartate aminotransferase serum levels
Measured: 6 months
improvement in the degree of liver fibrosis measured on a scale from 0 to 2
Liver biopsy: measured on a scale from 0 to 2
Measured: 6 months
to compare the occurrence of adverse effects between groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2024
- Study completionMar 2024
Why it stopped: lack of resources to finance the project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General de Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, MARIA DE FATIMA HIGUERA DE LA TIJERA, Hospital General de Mexico
- Investigators
- Fatima Higuera-de la Tijera, MD, MSc., Study director, Hospital General de México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541045
- Sponsor's protocol ID
- DI/15/108/03/48
- Status last verified
- Mar 2024
- First submitted
- 31 Aug 2015
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate the Efficacy of Metadoxine as a Therapy for Patients With Non-alcoholic Steatohepatitis
- ClinicalTrials.gov ID
- NCT02541045
- Acronym / sponsor ID
- DI/15/108/03/48
- Conditions
- Non-alcoholic Steatohepatitis
- Keywords
- non-alcoholic steatohepatitis, metadoxine, efficacy, therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of resources to finance the project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital General de MexicoOther government
- Study start
- Aug 2015 (actual)
- Primary completion
- Mar 2024 (actual)
- Study completion
- Mar 2024 (actual)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Placebo | Placebo comparator | Other: placeboPlacebo |
| Group 2: Metadoxine | Experimental | Drug: metadoxinetherapy with metadoxine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metadoxineAlso: Abrixone, Metadoxilmetadoxine 500mg tablets: 1 Tablet by mouth twice in day during 6 months | Drug | Group 2: Metadoxine |
| placeboplacebo tablets: 1 Tablet by mouth twice in day during 6 months | Other | Group 1: Placebo |
Primary outcome
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
7 secondary outcomes
improvement in liver steatosis measured on a scale from 0 to 3
Time frame: 6 months
improvement in lobular inflammation measured on a scale from 0 to 3
Time frame: 6 months
improvement in ballooning measured on a scale from 0 to 2
Time frame: 6 months
improvement in alanine aminotransferase serum levels
Time frame: 6 months
improvement in aspartate aminotransferase serum levels
Time frame: 6 months
improvement in the degree of liver fibrosis measured on a scale from 0 to 2
Time frame: 6 months
to compare the occurrence of adverse effects between groups
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatima Higuera-de la Tijera, MD, MSc. study director
Hospital General de México
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing metadoxine in people with Non-alcoholic Steatohepatitis, run by Hospital General de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in the degree of non-alcoholic fatty liver disease score (NAS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.