Study of Oral Treatments for Hepatitis C

Completed · Phase 4

Conditions studied: Chronic Hepatitis C

In brief

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.

Key facts

Study ID

NCT02786537

Run by

University of Florida

People needed

1275

Starts

2016-06-01

Expected to finish

2020-09-02

Last updated by the study team

2021-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HCV Genotype 1a or 1b
• Adult patients (age 18 years or older)
• Patients being prescribed HCV treatment who can begin treatment with any of the three HCV treatments being studied (Harvoni (SOF/LDV), Viekira Pak (PrOD) (Phase 1 only), or Zepatier (EBR/GZR))

You may not qualify if…

• Inability to provide written informed consent
• HARVONI® is not a covered drug on benefits formulary
• Current or historical evidence of hepatic decompensation (variceal bleeding, hepatic encephalopathy, or ascites)
• Child Pugh (CTP) B or C Cirrhosis (documented CTP calculation is required)
• Pregnant or breastfeeding women

Where it is running

• 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
• Mt. Sinai Beth Israel — New York, New York, United States

Full record on ClinicalTrials.gov

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