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Sponsored by: |
Hoffmann-La Roche |
Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00394277 |
This 4 arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus,and the efficacy and safety of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with chronic hepatitis C genotype 1 infection of high viral titer, and baseline body weight >=85kg, will be randomized to one of 4 groups, to receive a)PEGASYS 180 micrograms sc weekly plus Copegus 1200mg po daily, b)PEGASYS 180 micrograms sc weekly plus Copegus 1400-1600mg po daily, c)PEGASYS 360 micrograms sc weekly (induction) followed by 180 micrograms sc weekly (maintenance) plus Copegus 1200mg po daily or d)PEGASYS 360 micrograms sc weekly (induction) followed by 180 micrograms sc weekly (maintenance) plus Copegus 1400-1600mg po daily. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Condition | Intervention | Phase |
Hepatitis C, Chronic |
Drug: peginterferon alfa-2a (40KD) [PEGASYS] Drug: Copegus |
Phase IV |
MedlinePlus related topics: | Hepatitis Hepatitis C |
ChemIDplus related topics: | Ribavirin Peginterferon Alfa-2a |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind Study of the Effect on Sustained Viral Response, and the Safety, of Standard or 360 ug PEGASYS Induction Dosing in Combination With Standard or Higher Dose Copegus in Treatment-Naive Chronic Hepatitis C Patients Weighing >85kg With Genotype 1 High Viral Titer Infection |
Estimated Enrollment: | 1140 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | March 2009 |
Arms | Assigned Interventions |
1: Experimental |
Drug: peginterferon alfa-2a (40KD) [PEGASYS]
180 micrograms sc weekly for 48 weeks
Drug: Copegus
1200mg po daily for 48 weeks
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2: Experimental |
Drug: peginterferon alfa-2a (40KD) [PEGASYS]
180 micrograms sc weekly for 48 weeks
Drug: Copegus
1400-1600mg po daily for 48 weeks
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3: Experimental |
Drug: Copegus
1200mg po daily for 48 weeks
Drug: peginterferon alfa-2a (40KD) [PEGASYS]
360 micrograms sc weekly decreasing to 180 micrograms sc weekly for 48 weeks
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4: Experimental |
Drug: Copegus
1400-1600mg po daily for 48 weeks
Drug: peginterferon alfa-2a (40KD) [PEGASYS]
360 micrograms sc weekly decreasing to 180 micrograms sc weekly for 48 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Show 168 Study Locations |
Hoffmann-La Roche |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | NV18210 |
First Received: | October 30, 2006 |
Last Updated: | September 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00394277 |
Health Authority: | United States: Food and Drug Administration |
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