A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C
Public ClinicalTrials.gov record NCT00394277. 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
Randomized, Multicenter, Double-blinded, Phase IV Study Evaluating the Efficacy (as Measured by Sustained Virological Response) and Safety of 360 μg Induction Dosing of Pegasys® in Combination With Higher Copegus® Doses in Treatment-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Baseline Body Weight Greater Than or Equal to 85 kg
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This 4-arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus, and the efficacy and safety of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with chronic hepatitis C (CHC) genotype 1 infection of high viral titer, and baseline body weight ≥85 kg, will be randomized to one of 4 groups, to receive one of the following: a) PEGASYS 180 µg subcutaneously (sc) weekly plus Copegus 1200 mg orally (po) daily; b) PEGASYS 180 µg sc weekly plus Copegus 1400-1600 mg po daily; c)PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1200 mg po daily; or d) PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1400-1600 mg po daily. Following 48 weeks treatment, there will be a 24-week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Study identification
- NCT ID
- NCT00394277
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 1,175 participants
Conditions and interventions
Conditions
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 2007 (Type not available)
- Primary completion
- Apr 2009 (Actual)
- Completion
- Apr 2009 (Actual)
- Last update posted
- Aug 3, 2010
2007 – 2009
United States locations
- U.S. sites
- 91
- U.S. states
- 34
- U.S. cities
- 77
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | 35294 | — |
| Not listed | Huntsville | Alabama | 35801 | — |
| Not listed | Anchorage | Alaska | 99508 | — |
| Not listed | Phoenix | Arizona | 85006 | — |
| Not listed | Fresno | California | 93721 | — |
| Not listed | La Jolla | California | 92037-1030 | — |
| Not listed | Lancaster | California | 93534 | — |
| Not listed | Los Angeles | California | 90045 | — |
| Not listed | Los Angeles | California | 90095 | — |
| Not listed | Sacramento | California | 95817 | — |
| Not listed | San Diego | California | 92103-8465 | — |
| Not listed | San Diego | California | 92105 | — |
| Not listed | San Diego | California | 92123 | — |
| Not listed | San Diego | California | 92154 | — |
| Not listed | San Luis Obispo | California | 93401 | — |
| Not listed | San Marcos | California | 92069 | — |
| Not listed | Ventura | California | 93003 | — |
| Not listed | Aurora | Colorado | 80045 | — |
| Not listed | Englewood | Colorado | 80113 | — |
| Not listed | Washington D.C. | District of Columbia | 20010 | — |
| Not listed | Washington D.C. | District of Columbia | 20037 | — |
| Not listed | Jacksonville | Florida | 32209 | — |
| Not listed | Jacksonville | Florida | 32256 | — |
| Not listed | Miami | Florida | 33136-1051 | — |
| Not listed | North Miami Beach | Florida | 33162 | — |
| Not listed | Sarasota | Florida | 34243 | — |
| Not listed | Atlanta | Georgia | 30308 | — |
| Not listed | Austell | Georgia | 30106 | — |
| Not listed | Marietta | Georgia | 30060 | — |
| Not listed | Honolulu | Hawaii | 96817 | — |
| Not listed | Chicago | Illinois | 60612 | — |
| Not listed | Chicago | Illinois | 60637 | — |
| Not listed | Winfield | Illinois | 60190 | — |
| Not listed | Indianapolis | Indiana | 46202 | — |
| Not listed | Des Moines | Iowa | 50312 | — |
| Not listed | Iowa City | Iowa | 52242-1081 | — |
| Not listed | Iowa City | Iowa | 52246 | — |
| Not listed | Louisville | Kentucky | 40202 | — |
| Not listed | Baton Rouge | Louisiana | 70805 | — |
| Not listed | New Orleans | Louisiana | 70112 | — |
| Not listed | Boston | Massachusetts | 02720 | — |
| Not listed | Worcester | Massachusetts | 01068 | — |
| Not listed | Detroit | Michigan | 48210 | — |
| Not listed | Ypsilanti | Michigan | 48197 | — |
| Not listed | Plymouth | Minnesota | 55446 | — |
| Not listed | Kansas City | Missouri | 64131 | — |
| Not listed | St Louis | Missouri | 63104 | — |
| Not listed | St Louis | Missouri | 63110 | — |
| Not listed | Lebanon | New Hampshire | 03756 | — |
| Not listed | Egg Harbour Township | New Jersey | 08234 | — |
| Not listed | Vineland | New Jersey | 08360 | — |
| Not listed | Manhasset | New York | 11030 | — |
| Not listed | New York | New York | 10021 | — |
| Not listed | New York | New York | 10029 | — |
| Not listed | Rochester | New York | 14618 | — |
| Not listed | The Bronx | New York | 10467 | — |
| Not listed | Williamsville | New York | 14221 | — |
| Not listed | Yonkers | New York | 10701 | — |
| Not listed | Asheville | North Carolina | 28801 | — |
| Not listed | Chapel Hill | North Carolina | 27599-7080 | — |
| Not listed | Fayetteville | North Carolina | 28304 | — |
| Not listed | Cincinnati | Ohio | 45267 | — |
| Not listed | Cleveland | Ohio | 44106 | — |
| Not listed | Cleveland | Ohio | 44109 | — |
| Not listed | Tulsa | Oklahoma | 74104 | — |
| Not listed | Medford | Oregon | 97504 | — |
| Not listed | Lancaster | Pennsylvania | 17604-3200 | — |
| Not listed | Philadelphia | Pennsylvania | 19104 | — |
| Not listed | Philadelphia | Pennsylvania | 19107 | — |
| Not listed | Pittsburgh | Pennsylvania | 15213 | — |
| Not listed | Cranston | Rhode Island | 02920 | — |
| Not listed | Providence | Rhode Island | 02903 | — |
| Not listed | Columbia | South Carolina | 29204 | — |
| Not listed | Germantown | Tennessee | 38138 | — |
| Not listed | West Nashville | Tennessee | 37205 | — |
| Not listed | Dallas | Texas | 75203 | — |
| Not listed | Dallas | Texas | 75246 | — |
| Not listed | Dallas | Texas | 75390-9034 | — |
| Not listed | Fort Sam Houston | Texas | 78234-3879 | — |
| Not listed | Houston | Texas | 77030 | — |
| Not listed | Salt Lake City | Utah | 84121 | — |
| Not listed | Annandale | Virginia | 22003 | — |
| Not listed | Charlottesville | Virginia | 22906-0013 | — |
| Not listed | Chesapeake | Virginia | 23320-1706 | — |
| Not listed | Fairfax | Virginia | 22031 | — |
| Not listed | Richmond | Virginia | 23249 | — |
| Not listed | Seattle | Washington | 98104 | — |
| Not listed | Tacoma | Washington | 98405 | — |
| Not listed | Vancouver | Washington | 98664 | — |
| Not listed | Casper | Wyoming | 82609 | — |
| Not listed | Cheyenne | Wyoming | 82001 | — |
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 93 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00394277, 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 Aug 3, 2010 · Synced Oct 23, 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 NCT00394277 live on ClinicalTrials.gov.