Clinical Trial to Evaluate the Efficacy of Metadoxine as a Therapy for Patients With Non-alcoholic Steatohepatitis
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- improvement in the degree of non-alcoholic fatty liver disease score (NAS)
研究概览
简要总结
The aim of this study is to evaluate the efficacy of metadoxine as a therapy for patients with biopsy-proven non-alcoholic steatohepatitis.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group 1: Placebo
Placebo
干预措施: placebo (Other)
Group 2: Metadoxine
therapy with metadoxine
干预措施: metadoxine (Drug)
结局指标
主要结局
improvement in the degree of non-alcoholic fatty liver disease score (NAS)
时间窗: 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
次要结局
- improvement in alanine aminotransferase serum levels(6 months)
- improvement in aspartate aminotransferase serum levels(6 months)
- improvement in ballooning measured on a scale from 0 to 2(6 months)
- improvement in lobular inflammation measured on a scale from 0 to 3(6 months)
- to compare the occurrence of adverse effects between groups(6 months)
- improvement in liver steatosis measured on a scale from 0 to 3(6 months)
- improvement in the degree of liver fibrosis measured on a scale from 0 to 2(6 months)
研究者
MARIA DE FATIMA HIGUERA DE LA TIJERA
MD, MSc.
Hospital General de Mexico