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NCT01057667 · ClinicalTrials.gov registry record · Phase 2
A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4
A Phase 2 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 168
- Enrollment target
NCT01057667: Completed Phase 2 study, sponsored by Hoffmann-La Roche.
NCT01057667 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 168 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01057667, a Phase 2 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 168 participants
- Enrollment target
Study Summary
This equally randomized (1:1), double-blind, parallel arm study will assess the safety and antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). Patients achieving a rapid virological response (RVR) at week 4, sustained through week 22, will stop all treatment at week 24; non-RVR patients will continue treatment with Pegasys and Copegus for another 24 weeks up to week 48. Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks. Anticipated time on study treatment is up to 48 weeks. Target sample size is \<200.
Interventions
- DRUG RO5024048
- DRUG peginterferon alfa-2a [Pegasys]
- DRUG Ribavirin [Copegus]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2010-02 |
| Est. Completion | 2012-04 |
| Phase | Phase 2 |
What the finished NCT01057667 record still lists
NCT01057667 is an interventional study that assigns participants to a tested intervention. The registered 168 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 (26% higher).
The record links to 0 conditions, and to 3 interventions - of which RO5024048 is the first listed.
NCT01057667 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01057667 about?
NCT01057667 is a clinical study titled "A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4". This equally randomized (1:1), double-blind, parallel arm study will assess the safety and antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Patients in arm A will receive RO5024048...
What is the current status of trial NCT01057667?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 168 participants. The study started on 2010-02. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01057667?
The interventions under investigation include: RO5024048 (DRUG), peginterferon alfa-2a [Pegasys] (DRUG), Ribavirin [Copegus] (DRUG).
Who is sponsoring clinical trial NCT01057667?
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 NCT01057667's enrollment target sits among peer trials
168 403rd of 2000 higher than 1,595 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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