EUCTR2015-002560-16-AT进行中（未招募）1 期
A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis - REGENERATE
Intercept Pharmaceuticals Inc.0 个研究点目标入组 2,370 人开始时间: 2015年11月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,370
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Histologic evidence of NASH upon central read of a liver biopsy obtained no more than 6 months before Day 1 defined by presence of all 3 key histological features of NASH with a score of at least 1 for each and a combined score of 4 or greater out of a possible 8 points according to NASH CRN criteria.
- •2. Histologic evidence of fibrosis stage 2 or stage 3 as defined by the NASH CRN scoring of fibrosis, or
- •Histologic evidence of fibrosis stage 1a or stage 1b if accompanied by =1 of the following risk factors:
- •Obesity (BMI =30 kg/m2), Type 2 diabetes diagnosed per 2013 American Diabetes Association criteria, or ALT >1.5× upper limit of normal (ULN).
- •3. For subjects with a historical biopsy, is either not taking or is on stable doses of TZDs/glitazones or vitamin E for 6 months before Day 1.
- •4. Stable body weight.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2170
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •Key Exclusion Criteria:
- •1. Model for End-stage Liver Disease (MELD) score >12
- •2. ALT =10x ULN
- •3. HbA1c >9.5%
- •4. Total bilirubin >1.5 mg/dL
- •5. Evidence of other known forms of known chronic liver disease such as
- •alcoholic liver disease, hepatitis B, hepatitis C, PBC, PSC, autoimmune
- •hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency,
- •drug-induced liver injury, known or suspected hepatocellular carcinoma
- •6. History of liver transplant, or current placement on a liver transplant
- •7. Current or history of significant alcohol consumption
- •8. Prior or planned ileal resection, or prior or planned bariatric surgery
- •9. Histological presence of cirrhosis.
- •10. History of biliary diversion
- •11. Known positivity for human immunodeficiency virus infection.
- •12. Acute cholecystitis or acute biliary obstruction.
- •13. BMI>45 kg/m².
研究者
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