Sofosbuvir + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon
Public ClinicalTrials.gov record NCT01542788. 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 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 HCV Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN. Participants were randomized in a 3:1 ratio to receive sofosbuvir (SOF)+ribavirin (RBV), or placebo to match SOF+placebo to match RBV. Randomization was stratified by presence/absence of cirrhosis. Approximately 20% of participants may have had evidence of cirrhosis at screening.
Study identification
- NCT ID
- NCT01542788
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 278 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
- Mar 2012 (Type not available)
- Primary completion
- Nov 2012 (Actual)
- Completion
- Feb 2013 (Actual)
- Last update posted
- May 19, 2014
2012 – 2013
United States locations
- U.S. sites
- 50
- U.S. states
- 23
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35294-2170 | — |
| SCTI Research Foundation Liver Center | Coronado | California | 92118 | — |
| Kaiser Permanente | Los Angeles | California | 90027 | — |
| Lightspeed Medical | Los Angeles | California | 90036 | — |
| Anthony Mills MD, Inc. | Los Angeles | California | 90069 | — |
| Medical Associates Research Group | San Diego | California | 912123 | — |
| UCSD Antiviral Research Center | San Diego | California | 92103 | — |
| Kaiser Permanente | San Diego | California | 92154 | — |
| Quest Clinical Research | San Francisco | California | 94115 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| South Denver Gastroenterology | Englewood | Colorado | 80113 | — |
| Whitman Walker Clinic | Washington D.C. | District of Columbia | 20009 | — |
| University of Florida | Gainesville | Florida | 32610-0277 | — |
| Borland-Groover Clinic | Jacksonville | Florida | 32256 | — |
| University of Miami, Center for Liver Diseases | Miami | Florida | 33136 | — |
| Advanced Research Institute | New Port Richey | Florida | 34653 | — |
| Orlando Immunology Center (ACH) | Orlando | Florida | 32803-1851 | — |
| Internal Medicine Specialists | Orlando | Florida | 32806 | — |
| South Florida Center of Gastroenterology, P.A. | Wellington | Florida | 33414 | — |
| Digestive Healthcare of Georgia | Atlanta | Georgia | 30309 | — |
| Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | 30060 | — |
| Indianapolis Gastroenterology Research Foundation | Indianapolis | Indiana | 46237 | — |
| Graves-Gilbert Clinic | Bowling Green | Kentucky | 42101 | — |
| Gastroenterology Associates, LLC | Baton Rouge | Louisiana | 70809 | — |
| Johns Hopkins University | Lutherville | Maryland | 21093 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114-2696 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | — |
| The Research Institute | Springfield | Massachusetts | 01105 | — |
| Henry Ford Health System | Novi | Michigan | 48377 | — |
| Minnesota Gastroenterology, P.A. | Saint Paul | Minnesota | 55407 | — |
| Kansas City Gastroenterology and Hepatology | Kansas City | Missouri | 64131 | — |
| Comprehensive Clinical Research | Berlin | New Jersey | 08009 | — |
| ID Care | Hillsborough | New Jersey | 08844 | — |
| Binghamton Gastroenterology Associates | Binghamton | New York | 13903 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| Digestive Health Specialists, PA | Winston-Salem | North Carolina | 27103 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| University Gastroenterology | Providence | Rhode Island | 02905 | — |
| Gastro One | Germantown | Tennessee | 38138 | — |
| Nashville Gastrointestinal Specialists, Inc | Nashville | Tennessee | 37211 | — |
| Southwest Infectious Disease Clinical Research, Inc. | Dallas | Texas | 75219 | — |
| Therapeutic Concepts, PA | Houston | Texas | 77004 | — |
| Alamo Medical Research | San Antonio | Texas | 78215 | — |
| Metropolitan Research | Fairfax | Virginia | 22031 | — |
| Inova Fairfax Hospital Center for Liver Diseases | Falls Church | Virginia | 22042 | — |
| Liver Institute of Virginia, Bon Secours St.Mary's | Newport News | Virginia | 23602 | — |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | — |
| Virginia Mason Medical Center | 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 13 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01542788, 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 19, 2014 · Synced Oct 22, 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 NCT01542788 live on ClinicalTrials.gov.