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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00869661 |
Purpose
This 6-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. Group 6 provides retreatment on an open-label basis for patients of Group 5 who failed treatment. Patients will receive RO5024048 1000mg bid + Pegasys + Copegus for 24 weeks, followed by SOC for 24 weeks. The anticipated time on study treatment is 6-12 months.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C, Chronic |
Drug: RO5024048 Drug: Pegasys Drug: Copegus |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
| Enrollment: | 413 |
| Study Start Date: | February 2001 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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
|
| Experimental: 2 |
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
|
| Experimental: 3 |
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
|
| Experimental: 4 |
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
|
| Active Comparator: 5 |
Drug: Pegasys
180 micrograms sc weekly for 48 weeks
Drug: Copegus
1000/1200mg po daily for 48 weeks
|
| Experimental: 6 |
Drug: Pegasys
180 micrograms sc weekly for 48 weeks
Drug: Copegus
1000/1200mg po daily for 48 weeks
Drug: RO5024048
1000mg bid for 24 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 66 Study Locations| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
| Responsible Party: | Disclosures Group, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00869661 History of Changes |
| Other Study ID Numbers: | NV20536, 2008-008258-21 |
| Study First Received: | March 25, 2009 |
| Last Updated: | May 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Hepatitis Hepatitis A Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
Flaviviridae Infections Hepatitis, Chronic Ribavirin Peginterferon alfa-2a Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action |