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-Naïve Patients with Chronic Genotype 1 Hepatitis C Virus Infection - MK-5172 PhIIB study in treatment-naive patients.

Merck Sharp & Dohme Corp.,a subsidiary of Merck&Co.,Inc.0 个研究点目标入组 368 人开始时间: 2011年6月7日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•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.
•5. Patient had a liver biopsy within 3 years of screening or between screening and
•Day 1 with histology consistent with CHC and:
•No evidence of cirrhosis,no other etiology for chronic liver disease, a copy of the local pathology report must be available in the site’s file, availability of histology slides suitable for evaluation by the trial central pathologist.
•6. 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 from at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations.
•7; Patient has had a chest X-ray (unless prohibited by local regulations) within 6 months
•prior to the screening visit (or between the screening visit and Day 1.
•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) yes
•F.1.3.1 Number of subjects for this age range

•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.
•5. Patient has pre-exisiting psychiatric condition(s)
•6. Patient has a clinical diagnosis of substance abuse.
•7. Patient has any known medical condition that could interfere with the patient's participation in and completion of the trial.
•8. Patient has exclusionary laboratory values.
•9. Patient has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years
•10. 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.
•11. Patient has evidence or history of chronic hepatitis not caused by HCV,
•12. Patients had a life-threatening SAE during the screening period.

发起方

Merck Sharp & Dohme Corp.,a subsidiary of Merck&Co.,Inc.