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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 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 381 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01331850
The ClinicalTrials.gov registry entry for NCT01331850 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 381 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Copegus is the first listed.
NCT01331850 reports 0 study locations.
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.
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