A Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
Public ClinicalTrials.gov record NCT01225380. 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 Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of Response Guided Therapy With GS-9190, GS-9256, Ribavirin (Copegus®) and Peginterferon Alfa 2a (Pegasys®) in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection (Protocol No. GS-US-196-0123)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of response-guided duration of therapy with GS-9190 and GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®). Additionally, the efficacy and safety of 24 weeks of GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) will be evaluated.
Study identification
- NCT ID
- NCT01225380
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 324 participants
Conditions and interventions
Conditions
Interventions
- GS-9190 Drug
- GS-9256 Drug
- Pegasys® Biological
- Copegus® Drug
- GS-9190 placebo Drug
- GS-9256 placebo Drug
Drug · Biological
Eligibility (public fields only)
- Age range
- 18 Years to 70 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
- Sep 30, 2010
- Primary completion
- Dec 31, 2012
- Completion
- Aug 31, 2013
- Last update posted
- Jan 27, 2014
2010 – 2013
United States locations
- U.S. sites
- 36
- U.S. states
- 20
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | — |
| Advanced Clinical Research Institute | Anaheim | California | 92801 | — |
| Scripps Clinic | La Jolla | California | 92037 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Medical Associates Research Group | San Diego | California | 92123 | — |
| Kaiser Permanente | San Diego | California | 92154 | — |
| California Pacific Medical Center | San Francisco | California | 94115 | — |
| South Denver Gastroenterology | Englewood | Colorado | 80110 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| University of Miami Center for Liver Diseases | Miami | Florida | 33136 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| Bach and Godofsky Infectious Diseases | Sarasota | Florida | 34243 | — |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30308 | — |
| Emory University, Infectious Disease Clinic | Atlanta | Georgia | 30308 | — |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Gastroenterology Associates, LLC | Baton Rouge | Louisiana | 70809 | — |
| Johns Hopkins University | Lutherville | Maryland | 21093 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Southwest CARE Center | Santa Fe | New Mexico | 87505 | — |
| North Shore University Hospital | Great Neck | New York | 11021 | — |
| Concorde Medical Group | New York | New York | 10016 | — |
| Cornell University Gastroenterology & Hepatology | New York | New York | 10021 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| University Gastroenterology | Providence | Rhode Island | 02905 | — |
| Memphis Gastroenterology Group | Germantown | Tennessee | 38138 | — |
| The North Texas Research Institute | Arlington | Texas | 76012 | — |
| UT Southwestern Medical Center at Dallas | Dallas | Texas | 39090 | — |
| Alamo Medical Research | San Antonio | Texas | 78215 | — |
| Metropolitan Research | Fairfax | Virginia | 22031 | — |
| Liver Institute of Virginia, Bon Secours | Newport News | Virginia | 23602 | — |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | — |
| Virginia Mason Medical Center, Digestive Disease Institute | Seattle | Washington | 98101 | — |
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 78 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01225380, 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 Jan 27, 2014 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01225380 live on ClinicalTrials.gov.