Clinical trialNCT02786537CompletedPhase 4Interventional

Study of Oral Treatments for Hepatitis C

SponsorUniversity of FloridaEnrollment1,275Chronic Hepatitis C

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Phase 1 of this study compared the effectiveness of 3 approved DAA (direct-acting antiviral) HCV treatment regimens to learn whether they worked equally well under real-world conditions. Phase 2 of this study began early 2017 with removal of 1 DAA regimen, limiting randomization to just 2 FDA approved DAA regimens. Patients receiving HCV therapy in community and academic clinics were offered the opportunity to consent to be randomly assigned to one of three (phase 1) or one of two (phase 2) regimens and observed for outcomes. Once randomized, all medical care, laboratory testing, and any disease or side effect management were assumed by usual care conditions, and patient-reported outcomes were collected outside clinic in keeping with pragmatic design principles.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

David R Nelson, MD
University of Florida
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

38 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Liver Wellness Center
Little Rock, Arkansas, United States
Stanford University
Palo Alto, California, United States
Ucsd Medical Center
San Diego, California, United States
Ucsf/zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, United States
Univ of California, San Francisco
San Francisco, California, United States
Yale University Digestive Diseases
New Haven, Connecticut, United States
Georgetown University
Washington D.C., District of Columbia, United States
Howard University
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
University of Florida, Jacksonville
Jacksonville, Florida, United States
University of Miami/schiff Center for Liver Diseases
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Internal Medicine Associates of Wellstar Atlanta Medical Center
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
John Hopkins University
Lutherville, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Gi Associates & Endoscopy Center
Flowood, Mississippi, United States
Saint Louis University
St Louis, Missouri, United States
University of Nebraska Medical Ctr
Omaha, Nebraska, United States
Southwest Care Center
Santa Fe, New Mexico, United States
Columbia University Medical Center
New York, New York, United States
Mt. Sinai Beth Israel
New York, New York, United States
New York Langone Medical Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Mountain View Medical Center
Valatie, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Research Specialist of Texas
Houston, Texas, United States
Bon Secours St. Mary 'S Hospital of Richmond (liver Institute of Virginia)
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington
Seattle, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

EBR/GZRPrODRibavirin →SOF/LDV

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Jun 2016
Primary completion: 13 Jun 2019
Completion: 2 Sept 2020
Last update posted: 6 Dec 2021
Registered enrollment: 1,275
Registry id: NCT02786537

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.