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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00869661 |
This 5 arm study will assess the efficacy and safety of RO5024048 (R7128) in combination with the approved doses of Pegasys (180micrograms sc weekly) + Copegus (1000/1200mg po daily) (SOC), versus SOC in treatment-naive patients with chronic hepatitis C, genotype 1 and 4.The first 3 groups will receive 1) RO5024048 500mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks; 2)RO5024048 1000mg bid + Pegasys + Copegus for 8 weeks, followed by SOC for 16 weeks; 3) RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 12 weeks.After 24 weeks, patients in these 3 groups who have achieved rapid viral response will stop treatment, and those who have not will receive SOC for a further 24 weeks. Group 4 will receive RO5024048 1000mg bid + Pegasys + Copegus for 12 weeks, followed by SOC for 36 weeks, and group 5 will receive SOC for 48 weeks.
The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Condition | Intervention | Phase |
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Hepatitis C, Chronic |
Drug: RO5024048 Drug: Pegasys Drug: Copegus |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-blind, Multicenter, Dose and Duration Finding Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug (RO5024048) in Combination With Pegasys® and Ribavirin® (SOC) Versus SOC in Treatment-Naïve Patients With HCV Genotype 1 or 4 Infection |
Estimated Enrollment: | 400 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | July 2011 |
Arms | Assigned Interventions |
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1: Experimental |
Drug: RO5024048
500mg bid for 12 weeks
Drug: Pegasys
180 micrograms sc weekly for 24 or 48 weeks
Drug: Copegus
1000/1200mg po daily for 24 or 48 weeks
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2: Experimental |
Drug: RO5024048
1000mg bid for 8 weeks
Drug: Pegasys
180 micrograms sc weekly for 24 or 48 weeks
Drug: Copegus
1000/1200mg po daily for 24 or 48 weeks
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3: Experimental |
Drug: RO5024048
1000mg bid for 12 weeks
Drug: Pegasys
180 micrograms sc weekly for 24 or 48 weeks
Drug: Copegus
1000/1200mg po daily for 24 or 48 weeks
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4: Experimental |
Drug: RO5024048
1000mg bid for 12 weeks
Drug: Pegasys
180 micrograms sc weekly for 48 weeks
Drug: Copegus
1000/1200mg po daily for 48 weeks
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5: Active Comparator |
Drug: Pegasys
180 micrograms sc weekly for 48 weeks
Drug: Copegus
1000/1200mg po daily for 48 weeks
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Please reference Study ID Number: NV20536 | 973-235-5000 | |
Contact: or | 800-526-6367 (FOR US ONLY) |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | NV20536, 2008-008258-21 |
Study First Received: | March 25, 2009 |
Last Updated: | August 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00869661 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Anti-Infective Agents Liver Diseases Hepatitis, Chronic Ribavirin Hepatitis, Viral, Human Antiviral Agents |
Hepatitis Virus Diseases Signs and Symptoms Digestive System Diseases Peginterferon alfa-2a Hepatitis C Hepatitis C, Chronic |
Antimetabolites Anti-Infective Agents Liver Diseases RNA Virus Infections Molecular Mechanisms of Pharmacological Action Flaviviridae Infections Hepatitis, Chronic Ribavirin Hepatitis, Viral, Human |
Antiviral Agents Pharmacologic Actions Hepatitis Virus Diseases Digestive System Diseases Therapeutic Uses Peginterferon alfa-2a Hepatitis C Hepatitis C, Chronic |