EUCTR2011-004150-26-GB进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind Placebo-Controlled, Phase 2b Study to Compare the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir, Peginterferon-Alfa-2, Ribavirin) to Triple Therapy (with VX-222-Placebo) in Subjects With Genotype 1 Chronic Hepatitis C With Compensated Cirrhosis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 92
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
入选标准
- •- Subjects (male and female, including those of childbearing potential) must be between the ages of 18 and 70 years
- •- Subjects must have genotype 1 CHC and laboratory evidence of HCV infection for at least 6 months before the Screening Visit
- •- Subjects must have documentation of compensated cirrhosis
- •- Subjects must have never received treatment for hepatitis C (treatment naive) or must not have achieved SRV24 adter at least one prior course of Peg-IFN/RBV therapy of standard duration. For subjects who have previously received treatment, the last dose of Peg-IFN/RBV must have been at least 12 weeks before the Screening Visit
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Any previous treatment with an investigational drug or drug regimen for the treatment of hepatitis C, or previous treatment with an approved protease inhibitor
- •-History of any illness that, in the opinion of the investigator or general practitioner might confound the results of the study or pose an additional risk to the subject
- •- Any contraindication to Peg-IFN or RBV therapy, or history of severe AEs while on Peg-IFN or RBV
- •- Evidence of hepatic decompensation
- •- Any other cause of significant liver disease in addition to hepatitis C
- •- Diagnosed or suspected hepatocellular carcinoma
- •- History of organ transplant, with the exception of corneal transplants and skin grafts
- •- A medical condition that requires frequent or prolonged use of systemic corticosteroids or immunosuppressive drugs
- •- History of acute pancreatitis
- •- History or other clinical evidence of chronic pulmonary disease associated with functional impairment
- •- History of other evidence of sever retinopathy or clinically significant ophthalmological disorder
- •- History of illicit substance or alcohol abuse within 1 year before the Screening Visit
- •- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing
研究者
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