A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS Plus COPEGUS Compared With PEGASYS Plus COPEGUS in Patients With Chronic Hepatitis C Genotype 1 Infection.
Public ClinicalTrials.gov record NCT00517439. 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.
All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blinded Study to Evaluate the Safety and Effect on Sustained Virological Response of HCV Polymerase Inhibitor Pro-drug in Combination With PEGASYS Plus Copegus, Compared With the Currently Approved Combination of PEGASYS Plus Copegus, in Treatment-naïve Patients With Chronic he
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This 7 arm study will determine the optimal treatment combination, based on efficacy and safety. Patients with chronic hepatitis C (CHC), genotype 1, will be randomized to one of 7 treatment groups. Groups 1, 2, 4, 5 and 6 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (at doses of 500, 1000 or 1500mg po bid) plus PEGASYS (90 or 180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks, those achieving a rapid virological response (RVR) will stop all medication, and non-RVR patients will remain on triple combination for an additional 24 weeks. Group 7 will receive standard of care (SOC) for 48 weeks. There will be a 24 week period of treatment-free follow-up for all treatment groups. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study identification
- NCT ID
- NCT00517439
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 516 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 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
- Dec 2007 (Type not available)
- Primary completion
- Jan 2010 (Actual)
- Completion
- Jan 2010 (Actual)
- Last update posted
- Nov 2, 2016
2007 – 2010
United States locations
- U.S. sites
- 30
- U.S. states
- 17
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Phoenix | Arizona | 85054 | — |
| Not listed | La Jolla | California | 92037-1030 | — |
| Not listed | Long Beach | California | 90822 | — |
| Not listed | Sacramento | California | 95817 | — |
| Not listed | San Diego | California | 92103-8465 | — |
| Not listed | San Diego | California | 92154 | — |
| Not listed | San Francisco | California | 94115 | — |
| Not listed | Aurora | Colorado | 80045 | — |
| Not listed | Englewood | Colorado | 80110 | — |
| Not listed | Bradenton | Florida | 34209 | — |
| Not listed | Gainesville | Florida | 32610-0214 | — |
| Not listed | Miami | Florida | 33136-1051 | — |
| Not listed | Chicago | Illinois | 60637 | — |
| Not listed | Baltimore | Maryland | 21287 | — |
| Not listed | Plymouth | Minnesota | 55446 | — |
| Not listed | Manhasset | New York | 11030 | — |
| Not listed | New York | New York | 10021 | — |
| Not listed | The Bronx | New York | 10468 | — |
| Not listed | Chapel Hill | North Carolina | 27599-7584 | — |
| Not listed | Cincinnati | Ohio | 45267-0595 | — |
| Not listed | Portland | Oregon | 97239 | — |
| Not listed | Hershey | Pennsylvania | 17033 | — |
| Not listed | Providence | Rhode Island | 02905 | — |
| Not listed | Nashville | Tennessee | 37211 | — |
| Not listed | Dallas | Texas | 75203 | — |
| Not listed | Fort Sam Houston | Texas | 78234-3879 | — |
| Not listed | San Antonio | Texas | 78215 | — |
| Not listed | Salt Lake City | Utah | 84121 | — |
| Not listed | Fairfax | Virginia | 22031 | — |
| Not listed | Richmond | Virginia | 23249 | — |
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 33 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00517439, 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 Nov 9, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00517439 live on ClinicalTrials.gov.