EUCTR2008-000150-12-BE进行中（未招募）1 期
A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of 4 Different Regimens of MK-7009 When Administered Concomitantly with Pegylated Interferon and Ribavirin in Treatment-Experienced Patients with Chronic Genotype 1 Hepatitis C Virus Infection. - Add-on study of MK-7009 to PEG interferon and Ribavirin.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
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
- •Patients (men and women 18 to 65 years of age) with chronic compensated genotype 1 HCV infection as defined by 1) positive serology for HCV with HCV RNA levels =4 ×105 IU/mL in peripheral blood at screening (within 75 days prior to the first dose of MK-7009); 2) evidence of chronic HCV infection as assessed by positive serology for HCV or detectable HCV RNA =6 months prior to the first dose of MK-7009; and 3) absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease.
- •Patient has received and tolerated coadministered peg-IFN (alfa-2a or -2b) and RBV, but failed to respond to at least one prior treatment course of at least 12 weeks duration.
- •Patient has had a liver biopsy without evidence of cirrhosis
- •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
- •Patient has non-genotype 1 HCV infection, including mixed genotype and has evidence or history of chronic hepatitis not caused by HCV, including but not limited to non-alcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis.
研究者
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