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

Phase 2

Not yet recruiting

• Conditions: Chronic Hepatitis C; Hepatitis C virus infection; 10047438

• Registration Number: NL-OMON30320
• Lead Sponsor: Schering-Plough

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 5

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

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 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Efficacy Endpoint: The primary efficacy endpoint is the achievement of<br /><br>SVR, defined as plasma HCVRNA levels below the lower limit of detection at<br /><br>follow-up week 24 (FW 24). Subjects will be declared treatment failures in one<br /><br>of the following ways:<br /><br>* Subjects in any of the 5 treatment arms who are HCV-RNA positive at FW 24.<br /><br>* Subjects in any of the 5 treatment arms who are missing their HCV-RNA level<br /><br>at FW 24 and are not HCV-RNA negative at FW 12.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Key Secondary Efficacy Endpoint(s): The secondary endpoints in this study are:<br /><br>* The proportion of subjects with HCV-RNA levels below the limit of detection<br /><br>at FW 12.<br /><br>* The proportion of subjects with HCV-RNA levels below the limit of detection<br /><br>at 72 weeks post randomization.<br /><br>* The relationship between early virologic response (EVR) and SVR.<br /><br>* The relationship between virologic response at FW 12, FW 24 (SVR), and 72<br /><br>weeks post randomization.</p><br>