Comparison of PEG-Intron and Two Different Doses of Ribavirin for the Treatment of Chronic Hepatitis C In Treatment Naïve Subjects
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| First Received Date ICMJE | March 3, 2006 | ||||
| Last Updated Date | March 3, 2006 | ||||
| Start Date ICMJE | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of PEG-Intron and Two Different Doses of Ribavirin for the Treatment of Chronic Hepatitis C In Treatment Naïve Subjects | ||||
| Official Title ICMJE | Comparison of PEG Interferon Alfa-2b Plus Ribavirin Given as a Fixed Dose or on a Weight Optimized Basis for Treatment of Chronic Hepatitis C in Previously Untreated Adult Subjects | ||||
| Brief Summary | The purpose of this study is to compare PEG-interferon alfa-2b and two different doses of rivavirin for the treatment of chronic hepatitis C in previously untreated adult subjects |
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| Detailed Description | Primary Objective: This study will evaluate the safety and efficacy of two different PEG-interferon and Ribavirin regimens in patients who have not previously been treated for Hepatitis C. Patients have an equal chance to assignment to one of two treatment arms: Treatment Arm A: PEG-interferon 1.5 mcg/kg2 QW + Ribavirin 800 mg/day OR Treatment Arm B: PEG-interferon 1.5mcg/kg2 QW + Ribavirin 800 to 1400 mg/day Arm A & Arm B: Duration of treatment will be 48 weeks for genotype 1 patients and 24 or 48 weeks for genotype 2 or 3 patients. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Chronic Hepatitis C | ||||
| Intervention ICMJE | Drug: Ribavirin, PEG-Intron | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 5000 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Adult naive subjects with a diagnosis of compensated chronic hepatitis C (HCV RNA+) who have not previously been treated with interferon, PEG-interferon, ribavirin, or combination interferon + ribavirin are being selected for the study. |
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00299936 | ||||
| Other Study ID Numbers ICMJE | P02314, WIN-R | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Weill Medical College of Cornell University | ||||
| Collaborators ICMJE | Schering-Plough | ||||
| Investigators ICMJE |
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| Information Provided By | Weill Medical College of Cornell University | ||||
| Verification Date | March 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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