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| Tracking Information | |||||
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| First Received Date ICMJE | February 18, 2008 | ||||
| Last Updated Date | October 15, 2009 | ||||
| Start Date ICMJE | April 2008 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
SVR [ Time Frame: 24 weeks post-treatment (week 48 for Group 1, and week 72 for Group 2). ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00623428 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study of Combination Therapy With PEGASYS (Peginterferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response. | ||||
| Official Title ICMJE | A Randomized, Open-label Study of the Effects of 24 vs 48 Weeks of Combination Therapy With PEGASYS (Peginterferon Alfa-2a 40KD) Plus COPEGUS (Ribavirin) on Sustained Virological Response in Patients With Chronic Hepatitis C, Genotype 2 or 3 Who do Not Achieve a Rapid Viral Response. | ||||
| Brief Summary | This study will evaluate the efficacy and safety of PEGASYS + Copegus combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3. Patients receiving PEGASYS (180 micrograms sc weekly) + Copegus (800-1200mg po daily) who do not achieve a rapid viral response at week 4 will enter the study between treatment week 6 and 8, and will receive study medication. Those who have an early virological response at week 12, and are still taking medication at week 24, will then be randomized to one of 2 study groups. Group 1 will stop treatment at this point and will have a 48 week post-treatment observation period, and Group 2 will stay on medication for a further 24 weeks, followed by a 24 week post-treatment observation period. The anticipated time on study treatment is 6-12 months, and the target sample size is 100-500 individuals. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Hepatitis C, Chronic | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 400 | ||||
| Estimated Completion Date | May 2011 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States, Australia, Austria, Belgium, Brazil, Canada, Germany, Mexico, Puerto Rico, Switzerland | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00623428 | ||||
| Responsible Party | Disclosures Group, Hoffmann-La Roche | ||||
| Study ID Numbers ICMJE | MV21371, 2007-004993-15 | ||||
| Study Sponsor ICMJE | Hoffmann-La Roche | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Hoffmann-La Roche | ||||
| Verification Date | October 2009 | ||||
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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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