Overview

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

Status:
Suspended
Trial end date:
2023-08-01
Target enrollment:
0
Participant gender:
All
Summary
The aim of this study is to evaluate the efficacy of metadoxine as a therapy for patients with biopsy-proven non-alcoholic steatohepatitis.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hospital General de Mexico
Treatments:
Metadoxine
Pyridoxine
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.