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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 is a Phase 2 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 168 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01057667
The ClinicalTrials.gov registry entry for NCT01057667 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 168 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 RO5024048 is the first listed.
NCT01057667 reports 0 study locations.
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.
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