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| Descriptive Information Fields | |
| Brief Title † | SCH 503034 Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659)(COMPLETED) |
| Official Title † | PEG-Intron/REBETOL vs PEG-Intron/ SCH 503034 With and Without Ribavirin in Chronic Hepatitis C HCV-1 Peginterferon Alfa/Ribavirin Nonresponders: A SCH 503034 Dose-Finding Phase 2 Study |
| Brief Summary | The primary objective of this study is to determine the safe and effective dose range of SCH 503034 in combination with PEG-Intron in adult subjects who have chronic hepatitis C without cirrhosis, and who have failed an adequate course of combination therapy with peginterferon-alfa plus ribavirin. A secondary objective is to explore whether ribavirin provides an additional benefit when combined with PEG-Intron plus SCH 503034. |
| Detailed Description | |
| Study Phase | Phase II |
| Study Type † | Interventional |
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Primary Outcome Measure † | |
| Secondary Outcome Measure † | |
| Condition † | Chronic Hepatitis C |
| Intervention † | Drug: SCH 503034 |
| MEDLINE PMIDs | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Completed |
| Enrollment † | 300 |
| Start Date † | September 2005 |
| Completion Date | April 2007 |
| Eligibility Criteria † | Key inclusion criteria:
Key exclusion criteria:
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| Gender | Both |
| Ages | 18 Years to 65 Years |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | |
| Administrative Information Fields | |
| NCT ID † | NCT00160251 |
| Organization ID | P03659 |
| Secondary IDs †† | |
| Study Sponsor † | Schering-Plough |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | Schering-Plough |
| Verification Date | July 2007 |
| First Received Date † | September 8, 2005 |
| Last Updated Date | July 19, 2007 |