NCT00509210已完成1 期
Study of Telaprevir in Subjects With Hepatic Impairment
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Pharmacokinetics
研究概览
简要总结
The purpose of this study is to assess the safety and pharmacokinetics of Telaprevir following administration of multiple oral doses to subjects with moderate and severe hepatic impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Clinically diagnosed with Child Pugh score of 7-9 or greater than 10
- •Women of non-childbearing age
排除标准
- •Tested positive for HIV, Hepatitis C, Hepatitis B
结局指标
主要结局
Pharmacokinetics
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
A Phase 2a Study to Evaluate Viral Kinetics and Safety of Telaprevir in Participants With Genotype 2 or 3 Hepatitis C InfectionHepatitis C, ChronicNCT00561015Tibotec BVBA52
已完成
不适用
Hepatic Safety of Currently Used Antiretroviral Regimens in Patients With Chronic Hepatitis Under Real Life ConditionsHuman Immunodeficiency VirusHepatitis B, ChronicHepatitis C, ChronicNCT01908660Valme University Hospital192
终止
3 期
Telaprevir Plus Standard of Care (SOC) in HCV Associated Hepatocellular Carcinoma (HCC)InfectionNCT01821963M.D. Anderson Cancer Center1
已完成
1 期
A Study to Examine the Effects of Telaprevir on the Pharmacokinetics of Cyclosporine and Tacrolimus in Healthy AdultsHepatitis CNCT01038167Vertex Pharmaceuticals Incorporated20
终止
4 期
Telaprevir, Peg-IFN-alfa-2a, and RBV in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis CHepatitis CNCT01467492Vertex Pharmaceuticals Incorporated121