NCT00088140已完成2 期
A Dose Response Study of a Caspase Inhibitor in Hepatitis C Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 15
- 主要终点
- Median absolute change in aspartate transaminase (AST) values measured from baseline to Week 10
研究概览
简要总结
The purpose of this study is to determine if IDN-6556, when given orally, is safe and effective in patients with chronic hepatitis C virus infection.
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
- •Chronic hepatitis C infection
- •Unsuccessful prior HCV treatment
- •Liver impairment (either AST or ALT 1.5-10.0 x ULN)
- •Alpha-fetoprotein <= 50 ng/mL
- •Adequate hematologic parameters
排除标准
- •Decompensated or severe liver disease
- •Hepatocellular carcinoma
- •HIV infection
- •Co-infection with hepatitis B virus (HBV)
- •Renal impairment
- •Pancreatitis
- •Use of illicit or drugs of abuse
- •History of alcohol abuse
- •Presence of clinically significant cardiac arrhythmias
- •If female, pregnant or lactating
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
IDN-6556 5 mg twice a day (BID)
Active Comparator
干预措施: IDN-6556 (Drug)
IDN-6556 25mg twice a day (BID)
Active Comparator
干预措施: IDN-6556 (Drug)
IDN-6556 50 mg twice a day (BID)
Active Comparator
干预措施: IDN-6556 (Drug)
结局指标
主要结局
Median absolute change in aspartate transaminase (AST) values measured from baseline to Week 10
Median absolute change in alanine aminotransferase (ALT) values measured from baseline to Week 10
次要结局
未报告次要终点
研究者
研究点 (15)
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