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NCT01278134 · ClinicalTrials.gov registry record · Phase 2
A Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir With or Without Copegus (Ribavirin) in Interferon-Naïve Patients With Chronic Hepatitis C Genotype 1 (INFORM-SVR)
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 170
- Enrollment target
NCT01278134 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 170 participants.
The verdict
NCT01278134, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 170 participants
- Enrollment target
Study Summary
This multicenter, randomized, double-blind, parallel group study will evaluate the safety and efficacy of the combination RO5024048 and ritonavir-boosted danoprevir with and without Copegus (ribavirin) in patients with chronic hepatitis C genotype 1. In arm A and B, interferon treatment-naïve patients will receive 1000 mg RO5024048 orally twice daily and 100 mg danoprevir with 100 mg ritonavir orally twice daily plus either Copegus (1000 mg or 1200 mg orally daily) or placebo for 12 weeks. Depending on viral response and treatment arm patients will be re-randomized to continue assigned treatment for additional 12 weeks or stop all treatment. The anticipated time on study treatment is up to 24 weeks plus a 24-week follow-up. As of 29. September 2011, Arm B patients (placebo-containing arm) will be offered, in conjunction with the current treatment, Pegasys (peginterferon alfa-2a) 180 mcg subcutaneously weekly plus Copegus 1000mg or 1200 mg orally daily for 24 weeks, with a 24-week follow-up.
Interventions
- DRUG danoprevir
- DRUG RO5024048
- DRUG ribavirin [Copegus]
- DRUG peginterferon alfa-2a [Pegasys]
- DRUG Copegus placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2011-02 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01278134
The ClinicalTrials.gov registry entry for NCT01278134 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 170 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 5 interventions - of which danoprevir is the first listed.
NCT01278134 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01278134 about?
NCT01278134 is a clinical study titled "A Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir With or Without Copegus (Ribavirin) in Interferon-Naïve Patients With Chronic Hepatitis C Genotype 1 (INFORM-SVR)". This multicenter, randomized, double-blind, parallel group study will evaluate the safety and efficacy of the combination RO5024048 and ritonavir-boosted danoprevir with and without Copegus (ribavirin) in patients with chronic hepatitis C genotype 1. In arm A and B, interferon treatment-naïve patien...
What is the current status of trial NCT01278134?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 170 participants. The study started on 2011-02. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01278134?
The interventions under investigation include: danoprevir (DRUG), RO5024048 (DRUG), ribavirin [Copegus] (DRUG), peginterferon alfa-2a [Pegasys] (DRUG), Copegus placebo (DRUG).
Who is sponsoring clinical trial NCT01278134?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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