EUCTR2011-000759-18-IT进行中（未招募）1 期
A Randomized, Active-Controlled, Dose-Ranging Estimation Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-5172 When Administered Concomitantly with Peginterferon alfa-2b and Ribavirin in Treatment-Naive Patients with Chronic Genotype 1 Hepatitis C Virus Infection - MK5172-003-00
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
- 368
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
- •1. Patient is =18 years of age on day of signing informed consent 2. Patient has a body weight =40 kg (88 lbs) and = 125 kg (275 lbs). 3. Patient has previously documented CHC GT 1 infection. Patients with other or mixed genotypes are not eligible. 4. Patient has an HCV RNA value =10,000 IU/mL at screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 334
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 166
排除标准
- •1. Patient is HIV positive or know to be coinfected with hepatitis B virus (HBsAg positive). 2. Patient received prior approved or investigational treatment for hepatitis C: other than herbal remedies, except those with known hepatotoxicity. 3. Patient has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC. 4. Patient is diabetic and/or hypertensive with clinically significant ocular examination findings: retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or any other clinically significant abnormality. 5. Patient has pre-exisiting psychiatric condition(s) 6. Patient has any known medical condition that could interfere with the patient's participation in and completion of the trial. 7. Patient has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin). Patients under evaluation for malignancy are not eligible. 8. Female patient is pregnant, lactating, expecting to conceive or donate eggs OR male patient is planning to impregnate or provide sperm donation or has a female sexual partner of childbearing potential and is unwilling to commit to using two methods of birth control throughout treatment and after the completion of all treatment. 9. Patient 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. Note: Patients with history of acute non-HCV-related hepatitis, which resolved > 6 months before study entry, can be enrolled. 10. Patient has exclusionary laboratory values.
研究者
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