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NCT00517439 · ClinicalTrials.gov registry record · Phase 2
A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS Plus COPEGUS Compared With PEGASYS Plus COPEGUS in Patients With Chronic Hepatitis C Genotype 1 Infection.
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 516
- Enrollment target
NCT00517439: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT00517439 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 516 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (288% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00517439, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 516 participants
- Enrollment target
Study Summary
This 7 arm study will determine the optimal treatment combination, based on efficacy and safety. Patients with chronic hepatitis C (CHC), genotype 1, will be randomized to one of 7 treatment groups. Groups 1, 2, 4, 5 and 6 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (at doses of 500, 1000 or 1500mg po bid) plus PEGASYS (90 or 180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks, those achieving a rapid virological response (RVR) will stop all medication, and non-RVR patients will remain on triple combination for an additional 24 weeks. Group 7 will receive standard of care (SOC) for 48 weeks. There will be a 24 week period of treatment-free follow-up for all treatment groups. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Interventions
- DRUG Copegus
- DRUG Pegasys
- DRUG RO4588161
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 516 participants |
| Start Date | 2007-12 |
| Est. Completion | 2010-01 |
| Phase | Phase 2 |
What the finished NCT00517439 record still lists
NCT00517439 is an interventional study that assigns participants to a tested intervention. The registered 516 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (288% higher).
The record links to 0 conditions, and to 3 interventions - of which Copegus is the first listed.
NCT00517439 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00517439 about?
NCT00517439 is a clinical study titled "A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS Plus COPEGUS Compared With PEGASYS Plus COPEGUS in Patients With Chronic Hepatitis C Genotype 1 Infection.". This 7 arm study will determine the optimal treatment combination, based on efficacy and safety. Patients with chronic hepatitis C (CHC), genotype 1, will be randomized to one of 7 treatment groups. Groups 1, 2, 4, 5 and 6 will receive triple combination treatment with HCV polymerase inhibitor pro-d...
What is the current status of trial NCT00517439?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 516 participants. The study started on 2007-12. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00517439?
The interventions under investigation include: Copegus (DRUG), Pegasys (DRUG), RO4588161 (DRUG).
Who is sponsoring clinical trial NCT00517439?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00517439's enrollment target sits among peer trials
516 67th of 2000 higher than 1,934 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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