Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection
Public ClinicalTrials.gov record NCT01858766. 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 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Naive Subjects With Chronic HCV Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C virus (HCV) infection.
Study identification
- NCT ID
- NCT01858766
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 379 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
- Apr 2013 (Type not available)
- Primary completion
- May 2014 (Actual)
- Completion
- Aug 2014 (Actual)
- Last update posted
- Nov 14, 2018
2013 – 2014
United States locations
- U.S. sites
- 50
- U.S. states
- 19
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCSD | La Jolla | California | 92037 | — |
| University of California San Diego Medical Center | La Jolla | California | 92093 | — |
| VA Long Beach Healthcare System | Long Beach | California | 90822 | — |
| Los Angeles Medical Center | Los Angeles | California | 90027 | — |
| Ruane Peter J MD Incorporated | Los Angeles | California | 90036 | — |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | — |
| National Research Institute | Los Angeles | California | 90057 | — |
| Huntington Medical Research Institutes Liver Center | Pasadena | California | 91105 | — |
| Kaiser Permanente Medical Grp | San Diego | California | 92120 | — |
| Medical Associates Research Group, Inc. | San Diego | California | 92123 | — |
| Kaiser Permante | San Francisco | California | 94080 | — |
| University of Colorado | Denver | Colorado | 80220 | — |
| University of Florida Center for Clinical Trials Research | Gainesville | Florida | 32610 | — |
| Borland-Groover Clinic | Jacksonville | Florida | 32216 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| South Florida Center of Gastroenterology, P.A | Wellington | Florida | 33414 | — |
| Center For Hepatitis C/Atlanta Medical Center | Atlanta | Georgia | 30344 | — |
| Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | 30060 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | — |
| Indianapolis Gastroenterology & Hepatology, Inc.- ARC | Indianapolis | Indiana | 46237 | — |
| Mercy Medical Ctr | Baltimore | Maryland | 21202 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| ID Care | Hillsborough | New Jersey | 08844 | — |
| Southwest C.A.R.E. Center | Santa Fe | New Mexico | 87505 | — |
| North Shore/Long Island Jewish PRIME | Lake Success | New York | 11041 | — |
| Weill Cornell Medical College-New York Presbyterian Hospital | New York | New York | 10021 | — |
| Asheville Gastroenterology Associates, P.A. | Asheville | North Carolina | 28801 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Cumberland Research Associates, LLC | Fayetteville | North Carolina | 28303 | — |
| Digestive Health Specialists, PA | Winston-Salem | North Carolina | 27103 | — |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | — |
| UPMC Center For Liver Diseases | Pittsburgh | Pennsylvania | 15213 | — |
| VA Pittsburgh Healthcare System | Pittsburgh | Pennsylvania | 15240 | — |
| University Gastroenterology | Providence | Rhode Island | 02905 | — |
| Gastro One | Germantown | Tennessee | 38138 | — |
| Nashville Gastrointestinal Specialists Inc. | Nashville | Tennessee | 37211 | — |
| Texas Clinical Research Institute, LLC | Arlington | Texas | 76012 | — |
| Methodist Transplant Physicians | Dallas | Texas | 75203 | — |
| Alamo Medical Research, LTD d/b/a American Research Corporation | San Antonio | Texas | 78215 | — |
| Metropolitan Research | Fairfax | Virginia | 22031 | — |
| INOVA Institute of Research & Education | Falls Church | Virginia | 22042 | — |
| The Liver Institute of Virginia | Newport News | Virginia | 23602 | — |
| Digestive and Liver Disease Specialists, Ltd. | 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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01858766, 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 Nov 14, 2018 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01858766 live on ClinicalTrials.gov.