A Safety and Efficacy Study of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 400

Inclusion Criteria

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

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

Exclusion Criteria

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 hypersensitive subjects with clinically significant ocular exam findings: retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or any other clinically significant abnormality
5. Pre-existing psychiatric condition as specified in the protocol
6. Clinical diagnosis of substance abuse of the following drugs within the following timeframes (not including time spent in detoxification, hospitalization, or incarceration):
a. Alcohol, intravenous drugs, inhalational (not including marijuana), psychotropics, narcotics, cocaine use, prescription or over-the-counter drugs: within 1 year of the Screening visit.
b. Multi-drug abuse (2 or more substances in 6a): within 3 years of Screening visit OR
Subjects receiving opiate agonist substitution therapy within 1 year of Screening visit OR
Subject’s historic marijuana use is deemed excessive by the Principal Investigator (or physician listed on FDA Form 1572) or is interfering with the subject's life, then the subject is not eligible. If subject's marijuana use is not deemed excessive and does not interfere with life, subject must be instructed to discontinue any current use of recreational marijuana prior to entry into study and throughout the study period.
7. Any known pre-existing medical condition that could interfere with the subject’s participation in and completion of the study as specified in the protocol.
8. 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)
9. 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
10. Any other condition which, in the opinion of the Principal Investigator, or physician listed in FDA Form 1572 would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study.
11. 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. Collection of additional blood, urine, or tissue samples or additional data, beyond that specified in this protocol, is prohibited (other than that related to subject’s medical care).
12. Treatment with any investigation drug within 30 days of screening visit in this study.
13. Subjects who are part of the site personnel directly involved with this study.
14. Subjects who are family members of the investigational study staff.

Laboratory Exclusion Criteria
NOTE: If any of the laboratory exclusion criteria are met, then the site may have the subject retested. If a single value is more than 10% outside the listed laboratory exclusion criterion value, the clinical significance of this value may be discussed with the sponsor’s Project Physician for enrollment consideration.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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