Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV
Public ClinicalTrials.gov record NCT01701401. 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, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/- Ribavirin for 12 and 24 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.
Study identification
- NCT ID
- NCT01701401
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 870 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
- Sep 2012 (Type not available)
- Primary completion
- Mar 2014 (Actual)
- Completion
- Apr 2014 (Actual)
- Last update posted
- Nov 16, 2018
2012 – 2014
United States locations
- U.S. sites
- 53
- U.S. states
- 23
- U.S. cities
- 53
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | La Jolla | California | — | — |
| Not listed | Long Beach | California | — | — |
| Not listed | Los Angeles | California | — | — |
| Not listed | Palo Alto | California | — | — |
| Not listed | Sacramento | California | — | — |
| Not listed | San Diego | California | — | — |
| Not listed | Aurora | Colorado | — | — |
| Not listed | Englewood | Colorado | — | — |
| Not listed | Washington D.C. | District of Columbia | — | — |
| Not listed | Gainesville | Florida | — | — |
| Not listed | Miami | Florida | — | — |
| Not listed | Orlando | Florida | — | — |
| Not listed | Tampa | Florida | — | — |
| Not listed | Wellington | Florida | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Decatur | Georgia | — | — |
| Not listed | Marietta | Georgia | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Indianapolis | Indiana | — | — |
| Not listed | Baltimore | Maryland | — | — |
| Not listed | Lutherville | Maryland | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | Detroit | Michigan | — | — |
| Not listed | Rochester | Minnesota | — | — |
| Not listed | Saint Paul | Minnesota | — | — |
| Not listed | Kansas City | Missouri | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Hillsborough | New Jersey | — | — |
| Not listed | Albuquerque | New Mexico | — | — |
| Not listed | Santa Fe | New Mexico | — | — |
| Not listed | Manhasset | New York | — | — |
| Not listed | New York | New York | — | — |
| Not listed | The Bronx | New York | — | — |
| Not listed | Asheville | North Carolina | — | — |
| Not listed | Chapel Hill | North Carolina | — | — |
| Not listed | Durham | North Carolina | — | — |
| Not listed | Fayetteville | North Carolina | — | — |
| Not listed | Statesville | North Carolina | — | — |
| Not listed | Winston-Salem | North Carolina | — | — |
| Not listed | Cincinnati | Ohio | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Germantown | Tennessee | — | — |
| Not listed | Nashville | Tennessee | — | — |
| Not listed | Arlington | Texas | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Houston | Texas | — | — |
| Not listed | San Antonio | Texas | — | — |
| Not listed | Fairfax | Virginia | — | — |
| Not listed | Falls Church | Virginia | — | — |
| Not listed | Norfolk | Virginia | — | — |
| Not listed | Richmond | Virginia | — | — |
| Not listed | Seattle | Washington | — | — |
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 35 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01701401, 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 16, 2018 · Synced Oct 21, 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 NCT01701401 live on ClinicalTrials.gov.