A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) With or Without Pioglitazone in Treatment-Naive Patients With Chronic Hepatitis C and Insulin Resistance.
Public ClinicalTrials.gov record NCT00545233. 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, Open-label Study of the Effect of PEGASYS ® Plus COPEGUS® With or Without Concomitant Pioglitazone (Actos®) on Early Viral Kinetics in Treatment-naive Patients With Chronic Hepatitis C, Genotype-1, and Insulin Resistance
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This 2 arm study will assess the efficacy and safety of PEGASYS plus COPEGUS, with or without concomitant pioglitazone, on hepatitis C virus titers in treatment-naive patients with genotype 1 chronic hepatitis C, and insulin resistance. Patients will be randomized to receive either a)PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day (according to body weight) for 48 weeks or b)16 weeks of pioglitazone (30 mg daily for 8 weeks, then 45 mg daily for 8 weeks), followed by PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day + pioglitazone 45 mg daily for 48 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Study identification
- NCT ID
- NCT00545233
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 155 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
- Jan 2008 (Type not available)
- Primary completion
- Dec 2010 (Actual)
- Completion
- Dec 2010 (Actual)
- Last update posted
- May 7, 2012
2008 – 2010
United States locations
- U.S. sites
- 65
- U.S. states
- 32
- U.S. cities
- 56
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | 35294 | — |
| Not listed | Tucson | Arizona | 85710 | — |
| Not listed | Anaheim | California | 92801 | — |
| Not listed | Fresno | California | 93721 | — |
| Not listed | La Jolla | California | 92037-1030 | — |
| Not listed | Loma Linda | California | 92354 | — |
| Not listed | Los Angeles | California | 90048 | — |
| Not listed | Merced | California | 95340 | — |
| Not listed | Palo Alto | California | 94304 | — |
| Not listed | Pasadena | California | 91105 | — |
| Not listed | San Clemente | California | 92679 | — |
| Not listed | San Mateo | California | 94403 | — |
| Not listed | Englewood | Colorado | 80113 | — |
| Not listed | Littleton | Colorado | 80120 | — |
| Not listed | Hartford | Connecticut | 06015 | — |
| Not listed | Atlanta | Georgia | 30308 | — |
| Not listed | Chicago | Illinois | 60612 | — |
| Not listed | Downers Grove | Illinois | 60515 | — |
| Not listed | Indianapolis | Indiana | 46202 | — |
| Not listed | Indianapolis | Indiana | 46237 | — |
| Not listed | Iowa City | Iowa | 52242 | — |
| Not listed | Louisville | Kentucky | 40202-1798 | — |
| Not listed | New Orleans | Louisiana | 70112 | — |
| Not listed | Portland | Maine | 04102 | — |
| Not listed | Baltimore | Maryland | 21229 | — |
| Not listed | Boston | Massachusetts | 02215 | — |
| Not listed | Burlington | Massachusetts | 01805 | — |
| Not listed | Detroit | Michigan | 48201 | — |
| Not listed | Detroit | Michigan | 48202-2689 | — |
| Not listed | Duluth | Minnesota | 55805 | — |
| Not listed | Tupelo | Mississippi | 38801 | — |
| Not listed | Kansas City | Missouri | 64128 | — |
| Not listed | St Louis | Missouri | 63110-0250 | — |
| Not listed | Lebanon | New Hampshire | 03756 | — |
| Not listed | Egg Harbour Township | New Jersey | 08234 | — |
| Not listed | Hackensack | New Jersey | 07601 | — |
| Not listed | Bayside | New York | 11358 | — |
| Not listed | Manhasset | New York | 11030 | — |
| Not listed | New York | New York | 10003 | — |
| Not listed | New York | New York | 10021 | — |
| Not listed | New York | New York | 10029-6574 | — |
| Not listed | Asheville | North Carolina | 28801 | — |
| Not listed | Charlotte | North Carolina | 28203 | — |
| Not listed | Durham | North Carolina | 27710 | — |
| Not listed | Cincinnati | Ohio | 45219 | — |
| Not listed | Cincinnati | Ohio | 45242 | — |
| Not listed | Cincinnati | Ohio | 45267 | — |
| Not listed | Cleveland | Ohio | 44106 | — |
| Not listed | Dayton | Ohio | 45415 | — |
| Not listed | Tulsa | Oklahoma | 74104 | — |
| Not listed | Portland | Oregon | 97227 | — |
| Not listed | Portland | Oregon | 97239 | — |
| Not listed | Philadelphia | Pennsylvania | 19140 | — |
| Not listed | Philadelphia | Pennsylvania | 19141 | — |
| Not listed | Columbia | South Carolina | 29204 | — |
| Not listed | Nashville | Tennessee | 37211 | — |
| Not listed | Nashville | Tennessee | 37232 | — |
| Not listed | West Nashville | Tennessee | 37205 | — |
| Not listed | Dallas | Texas | 75246 | — |
| Not listed | Fort Sam Houston | Texas | 78234-3879 | — |
| Not listed | Houston | Texas | 77030 | — |
| Not listed | Lubbock | Texas | 79410 | — |
| Not listed | Salt Lake City | Utah | 84132 | — |
| Not listed | Charlottesville | Virginia | 22906-0013 | — |
| Not listed | Tacoma | Washington | 98405 | — |
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 NCT00545233, 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 May 7, 2012 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00545233 live on ClinicalTrials.gov.