A Safety and Efficacy Study of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C (CHC) Infected With Genotype 1 - n.a.

Schering-Plough0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

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•1. Subject must be between 18 and 60 years of age; 2. Subject*s body weight must be between 45 and 125 kg; 3. Subject must have documented chronic hepatitis C genotype 1 with most recent (within 6 months of Day 1) quantitative HCV-RNA result greater than or equal to 10,000 IU/mL; 4. Subject must have a liver biopsy within 5 years of Day 1 with histology consistent with chronic hepatitis and no other etiology for chronic liver disease. A copy of the local pathology report must be available in the site*s file; 5. Subject and subject's partner(s) must each agree to use acceptable methods of contraception 2 weeks prior to Day 1 and at least 6 months or longer if dictated by local regulations after last dose of study drug (see Section 7.6.1). 6. Subjects must be willing to give written informed consent

•1. Subjects who received prior treatment for hepatitis C
•2. Subjects known to be co-infected with HIV or hepatitis B virus (HBsAg positive)
•3. Evidence of decompensated liver disease as specified in the protocol
•4. Diabetic and hypertensive subjects with clinically significant ocular exam findings
•5. Pre-existing psychiatric condition as specified in the protocol
•6. Clinical diagnosis of substance abuse of drugs, see for details protocol.
•7. Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated basal cell carcinoma of the skin)
•8. Subjects who are pregnant or nursing. Subjects who intend to become pregnant during the study period. Male subjects with partners who are, or intend to become, pregnant during the study period
•9. Participation in any other clinical trial within 30 days of the screening visit or intention to participate in another clinical trial during participation in this study. Treatment with any investigation drug within 30 days of screening visit in this study.

发起方

Schering-Plough