EUCTR2009-012000-10-ES进行中（未招募）1 期
A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-7009 When Administered Concomitantly with Pegylated Interferon and Ribavirin in Treatment-Naïve Patients with Chronic Genotype 1 Hepatitis C Virus Infection ? Estudio de fase II, aleatorizado y controlado con placebo para evaluar la seguridad, tolerabilidad y eficacia de varias pautas de MK-7009 administrado de forma concomitante con interferón pegilado y ribavirina en pacientes con infección crónica por el virus de la hepatitis C de genotipo 1 no tratados previamente .
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
- 530
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patient (Men and women 18 to 65 years of age) has chronic genotype 1 HCV infection.
- •2. Patient has had a liver biopsy without evidence of cirrhosis.
- •3. Female patient who is of childbearing potential or male patient with female sexual partner who is of childbearing potential agrees to use two acceptable methods of birth control throughout treatment, and after completing all treatment, in accordance with the local peg-IFN and RBV product labels.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient had previous treatment with:
- •a. Three or more doses of IFN, peg-IFN, and/or RBV.
- •b. IFN, peg-IFN, and/or RBV and discontinued treatment due to intolerance to one or more of these therapies.
- •c. Other antiviral or investigational therapies or vaccines for HCV.
- •2. Female patient is pregnant or breastfeeding.
- •3. Patient has evidence or history of chronic hepatitis not caused by HCV.
- •4. Patient has HIV.
- •5. Patient has active hepatitis B infection.
- •6. Patient has non-genotype 1 HCV infection.
- •7. Patient consumes excessive amounts of alcohol.
研究者
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