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NCT00963885 · ClinicalTrials.gov registry record · Phase 2
A Study of RO5190591 (Danoprevir) in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1 Virus Infection
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 229
- Enrollment target
NCT00963885: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT00963885 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 229 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00963885, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 229 participants
- Enrollment target
Study Summary
This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus infection.In Part 1 of the study, patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours, 2) RO5190591 600mg po every 12 hours, 3) RO5190591 900mg po every 12 hours or 4) placebo, in combination with standard doses of Pegasys and Copegus. If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours or 2)placebo, in combination with standard doses of Pegasys and Copegus. The anticipated time on study treatment is 24-48 weeks, and the target sample size is 100-500 individuals.
Interventions
- DRUG Placebo
- DRUG Copegus
- DRUG Pegasys
- DRUG RO5190591 (Danoprevir)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 229 participants |
| Start Date | 2009-08 |
| Est. Completion | 2012-01 |
| Phase | Phase 2 |
What the finished NCT00963885 record still lists
NCT00963885 is an interventional study that assigns participants to a tested intervention. The registered 229 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 (72% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00963885 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00963885 about?
NCT00963885 is a clinical study titled "A Study of RO5190591 (Danoprevir) in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1 Virus Infection". This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus infection.In Part 1 of the study, pat...
What is the current status of trial NCT00963885?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 229 participants. The study started on 2009-08. Estimated completion is 2012-01.
What interventions are being tested in trial NCT00963885?
The interventions under investigation include: Placebo (DRUG), Copegus (DRUG), Pegasys (DRUG), RO5190591 (Danoprevir) (DRUG).
Who is sponsoring clinical trial NCT00963885?
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 NCT00963885's enrollment target sits among peer trials
229 264th of 2000 higher than 1,737 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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