EUCTR2011-004150-26-DE进行中（未招募）不适用
A Multicenter, Open-Label, Phase 2b Pilot Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir, Peginterferon-Alfa-2 and Ribavirin) in Subjects With Genotype 1 Chronic Hepatitis C With Compensated Cirrhosis
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 114
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
- •- 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 fit one of the following categories:
- •Treatment-naïve: never received treatment for hepatitis C
- •Prior null responder: had <2-log10 decrease from baseline in HCV RNA concentration at the Week 12 assessment after prior Peg-IFN/RBV treatment of at least 12 weeks.
- •Prior partial responder: had a =2-log10 decrease in HCV RNA concentration at the Week 12 assessment after prior Peg-IFN/RBV treatment of at least 12 weeks but never had undetectable HCV RNA levels while on treatment.
- •Prior relapser: had undetectable HCV RNA at EOT after prior Peg-IFN/RBV treatment of at least 12 weeks but detectable HCV RNA after the end of prior treatment.
- •For null and partial responders, the Week 12 assessment of HCV RNA response used should be from a sample collected between no earlier than Week 11 and no later than Week 16. If more than one assessment from this time period is available, the assessment closest to Week 12 should be used.
- •The following information related to the virologic response to the last course of Peg IFN/RBV therapy, if applicable, must be available in the medical records of the subject:
- •HCV RNA results before the start of treatment and at Week 12 assessment after start of treatment or documentation of the total treatment duration and log fold-change in HCV RNA.
- •Last dose of prior therapy must be at least 12 weeks before first dose of study drug given under this protocol.
- •- Subject s must have plasma HCV RNA of =4.0 log10 IU/mL (10000 IU/mL).
- •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 114
- •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
- •- Child-Pugh Score =7, or other clinical 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 before dosing
研究者
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