Trials / Completed
CompletedNCT01220947
A Study of Danoprevir Boosted With Low Dose Ritonavir in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Virus Infection
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 421 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This randomized, open-label, active-controlled, parallel-group study will evaluate the sustained virological response of danoprevir boosted with low dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in treatment-naive patients with chronic Hepatitis C.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Copegus | Copegus 1000 mg or 1200 mg po daily for 24 weeks. |
| DRUG | Danoprevir | Danoprevir 50 mg BID |
| DRUG | Danoprevir | Danoprevir 100 mg BID |
| DRUG | Danoprevir | Danoprevir 200 mg BID |
| DRUG | Pegasys | Pegasys 180 microgram sc qw |
| DRUG | Ritonavir | Ritonavir 100 mg |
Timeline
- Start date
- 2010-11-01
- Primary completion
- 2012-12-01
- Completion
- 2012-12-01
- First posted
- 2010-10-14
- Last updated
- 2016-11-02
Locations
68 sites across 11 countries: United States, Austria, Brazil, Canada, France, Germany, Italy, Mexico, Puerto Rico, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01220947. Inclusion in this directory is not an endorsement.