EUCTR2011-004150-26-PL进行中（未招募）不适用
A Multicenter, Open-Label, Phase 2b Pilot Study to Evaluate the Efficacyand Safety of Quadruple Therapy (VX-222, Telaprevir, Peginterferon-Alfa-2and Ribavirin) in Subjects With Genotype 1 Chronic Hepatitis C WithCompensated Cirrhosis
适应症
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
- •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
- •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
研究者
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