A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4
Public ClinicalTrials.gov record NCT01057667. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blinded, Multicenter Study to Evaluate the Antiviral Efficacy and Safety of Adding the HCV Polymerase Inhibitor Prodrug (RO5024048) for 24 Weeks to the Currently Approved Combination of Pegasys® and Copegus® in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 or 4
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01057667
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 168 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2010 (Type not available)
- Primary completion
- Apr 2012 (Actual)
- Completion
- Apr 2012 (Actual)
- Last update posted
- Nov 2, 2016
2010 – 2012
United States locations
- U.S. sites
- 19
- U.S. states
- 15
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | La Jolla | California | 92037-1030 | — |
| Not listed | Bradenton | Florida | 34209 | — |
| Not listed | Atlanta | Georgia | 30309 | — |
| Not listed | Honolulu | Hawaii | 96813 | — |
| Not listed | Honolulu | Hawaii | 96817 | — |
| Not listed | Chicago | Illinois | 60637 | — |
| Not listed | Indianapolis | Indiana | 46202 | — |
| Not listed | Kansas City | Kansas | 66160 | — |
| Not listed | Kansas City | Missouri | 64131 | — |
| Not listed | Lebanon | New Hampshire | 03756 | — |
| Not listed | Albuquerque | New Mexico | 87131 | — |
| Not listed | New York | New York | 10003 | — |
| Not listed | New York | New York | 10021 | — |
| Not listed | The Bronx | New York | 10468 | — |
| Not listed | Philadelphia | Pennsylvania | 19104 | — |
| Not listed | Columbia | South Carolina | 29204 | — |
| Not listed | Nashville | Tennessee | 37232 | — |
| Not listed | Houston | Texas | 77030 | — |
| Not listed | San Antonio | Texas | 78234 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01057667, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 2, 2016 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01057667 live on ClinicalTrials.gov.