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)
Public ClinicalTrials.gov record NCT01278134. 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
INFORM-SVR: A Randomized, Multi-Center Study of Interferon-Free Treatment With a Combination of a Polymerase Inhibitor (RO5024048) and a Ritonavir Boosted HCV Protease Inhibitor (RO5190591/r, DNV/r) With or Without Copegus® in Interferon Naïve HCV Genotype 1 Infected Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01278134
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 170 participants
Conditions and interventions
Conditions
Interventions
- Copegus placebo Drug
- RO5024048 Drug
- danoprevir Drug
- peginterferon alfa-2a [Pegasys] Drug
- ribavirin [Copegus] Drug
- ritonavir Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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 2011 (Type not available)
- Primary completion
- Oct 2012 (Actual)
- Completion
- Oct 2012 (Actual)
- Last update posted
- Nov 2, 2016
2011 – 2012
United States locations
- U.S. sites
- 18
- U.S. states
- 16
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | La Jolla | California | 92037-1030 | — |
| Not listed | Sacramento | California | 95817 | — |
| Not listed | Orlando | Florida | 32809 | — |
| Not listed | Marietta | Georgia | 30060 | — |
| Not listed | Honolulu | Hawaii | 96814 | — |
| Not listed | Honolulu | Hawaii | 96817 | — |
| Not listed | Chicago | Illinois | 60637 | — |
| Not listed | Indianapolis | Indiana | 46202 | — |
| Not listed | Lutherville | Maryland | 21093 | — |
| Not listed | Detroit | Michigan | 48202 | — |
| Not listed | Newark | New Jersey | 07102 | — |
| Not listed | Albuquerque | New Mexico | 87131 | — |
| Not listed | New York | New York | 10021 | — |
| Not listed | Providence | Rhode Island | 02905 | — |
| Not listed | Nashville | Tennessee | 37211 | — |
| Not listed | Houston | Texas | 77030 | — |
| Not listed | Newport News | Virginia | 23602 | — |
| Not listed | Vancouver | Washington | 98664 | — |
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 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01278134, 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 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01278134 live on ClinicalTrials.gov.