A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection.
Public ClinicalTrials.gov record NCT00377182. 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-blind Study to Evaluate the Safety and Tolerability of the HCV Polymerase Inhibitor Pro-drug in Combination With Pegasys, With or Without Copegus, Versus Pegasys Plus Copegus, in Treatment-naïve Patients With Chronic Hepatitis C, Genotype 1
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This 4 arm study will compare the safety and tolerability of HCV polymerase inhibitor pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of PEGASYS + COPEGUS, in treatment-naive patients with CHC, genotype 1. Patients will be randomized to receive 1500mg or 3000mg po bid of HCV polymerase inhibitor pro-drug + PEGASYS, 1500mg of HCV polymerase inhibitor pro-drug + PEGASYS + COPEGUS or PEGASYS + COPEGUS for 4 weeks. All patients who receive at least one dose of study medication will receive open label PEGASYS + Copegus for an additional 44 weeks after the 4 week experimental period. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
Study identification
- NCT ID
- NCT00377182
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 107 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
- Aug 31, 2006
- Primary completion
- Jul 31, 2008
- Completion
- Jul 31, 2008
- Last update posted
- Nov 1, 2016
2006 – 2008
United States locations
- U.S. sites
- 17
- U.S. states
- 9
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 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 | Bradenton | Florida | 34209 | — |
| Not listed | Gainesville | Florida | 32610-0214 | — |
| Not listed | Chicago | Illinois | 60637 | — |
| Not listed | Novi | Michigan | 48377 | — |
| Not listed | Manhasset | New York | 11030 | — |
| Not listed | New York | New York | 10029 | — |
| Not listed | Chapel Hill | North Carolina | 27599-7584 | — |
| Not listed | Dallas | Texas | 75203 | — |
| Not listed | Fort Sam Houston | Texas | 78234-3879 | — |
| 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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00377182, 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 1, 2016 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00377182 live on ClinicalTrials.gov.