Phase 3 Study of Sofosbuvir and Ribavirin
Public ClinicalTrials.gov record NCT01497366. 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, Active-Controlled Study to Investigate the Safety and Efficacy of PSI-7977 and Ribavirin for 12 Weeks Compared to Pegylated Interferon and Ribavirin for 24 Weeks in Treatment-Naïve Patients With Chronic Genotype 2 or 3 HCV Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.
Study identification
- NCT ID
- NCT01497366
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 527 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
- Dec 2011 (Type not available)
- Primary completion
- Jan 2013 (Actual)
- Completion
- Apr 2013 (Actual)
- Last update posted
- Apr 2, 2014
2011 – 2013
United States locations
- U.S. sites
- 67
- U.S. states
- 24
- U.S. cities
- 58
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Alabama Liver & Digestive Specialist | Montgomery | Alabama | 36116 | — |
| Franco Felizarta, MD | Bakersfield | California | 93301 | — |
| California Liver Institute | Beverly Hills | California | 90210 | — |
| Arrowhead Regional Medical Center | Colton | California | 92324 | — |
| SCTI Research Foundation | Coronado | California | 92118 | — |
| eStudy Site | La Mesa | California | 91940 | — |
| Peter J. Ruane, M.D. Inc. | Los Angeles | California | 90036 | — |
| eStudySite | Oceanside | California | 92056 | — |
| University of California, Davis - Health System | Sacramento | California | 95817 | — |
| University of California San Diego Medical Center | San Diego | California | 92103 | — |
| Research and Education, Inc. | San Diego | California | 92105 | — |
| Medical Associates Research Group, Inc. | San Diego | California | 92123 | — |
| Quest Clinical Research | San Francisco | California | 94115 | — |
| South Denver Gastroenterology, PC | Englewood | Colorado | 80113 | — |
| Pointe West Infectious Diseases | Bradenton | Florida | 34209 | — |
| Midway Immunology & Research Center, LLC | Ft. Pierce | Florida | 34982 | — |
| University of Florida College of Medicine | Gainesville | Florida | 32610 | — |
| Borland-Groover Clinic Baptist | Jacksonville | Florida | 32256 | — |
| University of Miami, School of Medicine | Miami | Florida | 33136 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| Internal Medicine Specialists | Orlando | Florida | 32806 | — |
| Advanced Research Institute | Trinity | Florida | 34655 | — |
| South Florida Center of Gastroenterology | Wellington | Florida | 33414 | — |
| AIDS Research Consortium of Atlanta, Inc. | Atlanta | Georgia | 30308 | — |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30308 | — |
| Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | 30060 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Indianapolis Gastroenterology Research Foundation | Indianapolis | Indiana | 46237 | — |
| Digestive Disease Associates, P.A. | Baltimore | Maryland | 21229 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | — |
| The Research Institute | Springfield | Massachusetts | 01105 | — |
| Partners in Internal Medicine, PC | Worcester | Massachusetts | 01608-1320 | — |
| University of Massachusetts, Worcester | Worcester | Massachusetts | 01655 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Digestive Health Specialists, PA | Tupelo | Mississippi | 38801 | — |
| Veterans Affairs Medical Center | East Orange | New Jersey | 07018 | — |
| AGA Clinical Research Associates, LLC | Egg Harbor | New Jersey | 08234 | — |
| ID Care | Hillsborough | New Jersey | 08844 | — |
| Atlantic Research Affiliates, LLC | Morristown | New Jersey | 07960 | — |
| Southwest C.A.R.E. Center | Santa Fe | New Mexico | 87505 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| University of Rochester | Rochester | New York | 14662 | — |
| Asheville Gastroenterology Associates, P.A. | Asheville | North Carolina | 28801 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Carolinas Center for Liver Disease | Statesville | North Carolina | 28677 | — |
| Digestive Health Specialists, PA | Winston-Salem | North Carolina | 27103 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| Gastroenterology United of Tulsa | Tulsa | Oklahoma | 74135 | — |
| Schleinitz Research and Gastroenterology LLC | Medford | Oregon | 97504 | — |
| Regional Gastroenterology Associates of Lancaster, Ltd. | Lancaster | Pennsylvania | 17604 | — |
| UPMC Center For Liver Diseases | Pittsburgh | Pennsylvania | 15213 | — |
| University Gastroenterology | Warwick | Rhode Island | 02886 | — |
| Gastro One | Germantown | Tennessee | 38138 | — |
| Nashville Gastrointestinal Specialists Inc. | Nashville | Tennessee | 37211 | — |
| Texas Clinical Research Institute, LLC | Arlington | Texas | 76012 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
| Kelsey-Seybold Clinic PA | Houston | Texas | 77005 | — |
| Research Specialists of Texas | Houston | Texas | 77030 | — |
| VAMC & Baylor College | Houston | Texas | 77030 | — |
| Alamo Medical Research | San Antonio | Texas | 78215 | — |
| Metropolitan Research | Fairfax | Virginia | 22031 | — |
| Digestive and Liver Disease Specialist, Ltd. | Norfolk | Virginia | 23502 | — |
| 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 30 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01497366, 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 Apr 2, 2014 · Synced Oct 27, 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 NCT01497366 live on ClinicalTrials.gov.