Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- The Primary Outcome Will be Improvement in Hepatic Steatosis by Liver MRI
研究概览
简要总结
The purpose of the study is to see if the drug colesevelam is a potential treatment for Nonalcoholic Steatohepatitis(NASH).
详细描述
We plan to investigate the role of colesevelam, a bile-acid binding resin, in patients with NASH residing in the United States and assess liver fat changes during therapy using MRI of the liver. It can be hypothesized that colesevelam would lead to a greater improvement in insulin sensitivity and lipid profile compared with placebo and may lead to greater improvement in liver fat by MRI as compared to placebo.
In this pilot study, we propose to randomize approximately 55 patients (1:1 ratio) to either colesevelam or placebo and treat them for 24-weeks to evaluate changes in baseline insulin sensitivity, serum biochemistry (ALT and AST), and liver fat by MRI during therapy. Liver histologic changes would also be examined as an exploratory outcome for future studies.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at entry at least 18 years.
- •Serum alanine (ALT) or aspartate (AST) aminotransferase activities that are above the upper limits of normal. 19 or more in women and 30 or more in men.
- •Evidence of hepatic steatosis or liver fat (>5%) by MRI.
- •Evidence of definite or suspected NASH
- •Written informed consent.
- •Exclusion criteria:
- •Evidence of another form of liver disease.
- •History of excess alcohol ingestion.
- •Contraindications to liver biopsy.
- •Decompensated liver disease.
- •History of gastrointestinal bypass surgery or ingestion of drugs known to produce hepatic steatosis.
- •Recent initiation or change of anti-diabetic drugs.
- •Use of colesevelam or other agents in the same class.
- •Significant systemic or major illnesses other than liver disease that, in the opinion of the investigator would preclude treatment with colesevelam and adequate follow up.
- •Positive test for anti-HIV.
- •Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year.
- •Pregnancy or inability to practice adequate contraception in women of childbearing potential.
- •Evidence of hepatocellular carcinoma
排除标准
- 未提供
研究组 & 干预措施
Placebo (sugar) pill
Six tablets per day (identical to colesevelam)
干预措施: Colesevelam Hcl (Drug)
Colesevelam arm
3.75 grams per day
干预措施: Colesevelam Hcl (Drug)
结局指标
主要结局
The Primary Outcome Will be Improvement in Hepatic Steatosis by Liver MRI
时间窗: 24 weeks
To examine the efficacy of Colesevelam at 3.75 g/day orally versus placebo to decrease liver fat in patients with biopsy-proven nonalcoholic steatohepatitis.
次要结局
- Lipid Profiles(24 weeks)
- Insulin Sensitivity as Determined by HOMA-IR(24 weeks)
- Serum ALT and AST Values(24 weeks)
研究者
Rohit Loomba
Professor
University of California, San Diego