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NCT01331850 · ClinicalTrials.gov registry record · Phase 2
A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys in Patients With Chronic Hepatitis C
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 381
- Enrollment target
NCT01331850: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT01331850 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 381 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (186% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01331850, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 381 participants
- Enrollment target
Study Summary
This randomized, open-label, multi-center study will evaluate the sustained virological response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection. Patients will be divided into 2 separate cohorts. Cohort A, previous partial responders, will be randomized to Groups 1-3 and cohort B, previous null responders, will be randomized to Groups 4-6. Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Groups 1 and 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Groups 3, 5 and 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment.
Interventions
- DRUG Copegus
- DRUG Pegasys
- DRUG RO5024048
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 381 participants |
| Start Date | 2011-05 |
| Est. Completion | 2013-01 |
| Phase | Phase 2 |
What the finished NCT01331850 record still lists
NCT01331850 is an interventional study that assigns participants to a tested intervention. The registered 381 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 (186% higher).
The record links to 0 conditions, and to 3 interventions - of which Copegus is the first listed.
NCT01331850 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01331850 about?
NCT01331850 is a clinical study titled "A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys in Patients With Chronic Hepatitis C". This randomized, open-label, multi-center study will evaluate the sustained virological response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection. Patients will be divided into 2 sep...
What is the current status of trial NCT01331850?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 381 participants. The study started on 2011-05. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01331850?
The interventions under investigation include: Copegus (DRUG), Pegasys (DRUG), RO5024048 (DRUG).
Who is sponsoring clinical trial NCT01331850?
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 NCT01331850's enrollment target sits among peer trials
381 111th of 2000 higher than 1,890 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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