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Completed Phase 3 Interventional Results available

Phase 3 Study of Sofosbuvir and Ribavirin

ClinicalTrials.gov ID: NCT01497366

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.

ClinicalTrials.gov public records Last synced Jun 25, 2026, 9:50 PM EDT

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

Study identification

NCT ID
NCT01497366
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Gilead Sciences
Industry
Enrollment
527 participants

Conditions and interventions

Conditions

Interventions

  • Sofosbuvir Drug
  • PEG Drug
  • RBV Drug

Drug

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
Nov 30, 2011
Primary completion
Dec 31, 2012
Completion
Mar 31, 2013
Last update posted
Apr 1, 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 1, 2014 · Synced Jun 25, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01497366 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →