Study of Oral Treatments for Hepatitis C



Status:Active, not recruiting
Conditions:Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:1/31/2019
Start Date:June 2016
End Date:February 2022

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THE PRIORITIZE STUDY: A Pragmatic, Randomized Study of Oral Regimens for Hepatitis C: Transforming Decision-Making for Patients, Providers, and Stakeholders

Phase 1 of this study will compare the effectiveness of 3 approved HCV treatment regimens to
learn whether they work equally well under real-world conditions. Phase 2 of this study will
begin early 2017 and will compare the effectiveness of 2 FDA approved HCV treatments.
Patients receiving HCV therapy in community and academic clinics will be offered the
opportunity to consent to be randomly assigned to one of three regimens and then observed for
outcomes. Once randomized, all medical care, laboratory testing, and any disease or side
effect management will be assumed by usual care conditions, and patient-reported outcomes
will be collected outside clinic in keeping with pragmatic design principles.

In Phase 1 of this study, consented subjects will be randomized to 1 of the following 3 HCV
treatments:

1) Harvoni® 2)Viekira Pak™ 3)Zepatier™ (The addition of Ribavirin and the length of treatment
will be determined by the provider). In Phase 2 of this study, consented subjects will be
randomized to 1 of 2 FDA approved HCV treatments: 1)1) Harvoni® or 3)Zepatier™. Both Phase 1
and Phase 2 subjects will have up to 1 tablespoon of blood drawn for HCV resistance testing
and future biorepository testing (if subject provides additional consent). The results of
testing will determine whether a genotype 1a subject will be provided 12 or 16 wks of
Zepatier (if randomized to Zepatier).

Following randomization, subjects will complete patient reported outcome questionnaires via
electronic device or telephone. Following randomization, subjects will be asked to complete
surveys again at Wk 4 of treatment, End of Treatment, 1 and 3 year post treatment. Subjects
standard medical care will continue. Test results and medical records throughout treatment
and for up to 3 years post treatment will be collected.

Inclusion Criteria:

- 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, Viekira Pak (Phase 1 only), or Zepatier)

Exclusion Criteria:

- 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
We found this trial at
37
sites
Little Rock, Arkansas 72205
Principal Investigator: Alonzo Williams, MD
Phone: 501-687-9300
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Ray Chung, MD
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Michael W. Fried, M.D
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Giuseppe Morelli, M.D.
Phone: 352-273-9500
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Mohamed Hassan, MD
Phone: 612-624-9926
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Charles Landis, MD, PHD
Phone: 206-744-3402
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Anna SF Lok, MD
Phone: 734-647-0236
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Atlanta, Georgia 30312
Principal Investigator: Brian Pearlman, MD
Phone: 404-265-4194
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Josh Levitsky, MD
Phone: 312-694-0243
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
Principal Investigator: Kenneth Sherman, MD
Phone: 513-584-2363
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Andrew Muir, MD
Phone: 919-681-2941
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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2510 Lakeland Drive
Flowood, Mississippi 39232
Principal Investigator: Brian Borg, MD
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Houston, Texas 77030
Principal Investigator: Joseph Galati, MD
Phone: 713-634-5110
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545 Barnhill Dr
Indianapolis, Indiana 46201
(317) 274-8157
Principal Investigator: Howard Masouka, MD, PhD
Phone: 317-278-4633
Indiana University Medical Center Indiana University Health is Indiana
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Jacksonville, Florida 32209
Principal Investigator: Miguel Malespin, MD
Phone: 904-633-0070
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Lutherville, Maryland 21218
Phone: 443-287-9605
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Miami, Florida 33136
Principal Investigator: Eugene Schiff, MD
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New Haven, Connecticut 06520
Principal Investigator: Joseph Lim, MD
Phone: 203-785-2204
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New York, New York 10021
Principal Investigator: Robert Brown, MD
Phone: 646-962-2085
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New York, New York 10003
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Elizabeth Verna, MD
Phone: 212-305-3839
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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New York, New York 10016
Principal Investigator: James Park, MD
Phone: 212-263-0155
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Mark Mailliard, MD
Phone: 402-559-3652
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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1701 North Mills Avenue
Orlando, Florida 32803
(407)647-3960
Principal Investigator: Federico Hinestrosa, MD
Phone: 407-409-7125
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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Palo Alto, California 94304
Principal Investigator: Glen Lutchman, MD
Phone: 650-721-8614
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Rajender Reddy, MD
Phone: 215-615-3755
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Richmond, Virginia 23226
Principal Investigator: Mitchell L. Shiffman, MD
Phone: 804-977-8921
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Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Richard Sterling, MD
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Saint Louis, Missouri 63110
Principal Investigator: Adrian DiBisceglie, MD
Phone: 314-977-9400
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34800 Bob Wilson Drive
San Diego, California 92103
Principal Investigator: Irine Vodkin, MD
Phone: 858-657-5147
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San Francisco, California 94143
Principal Investigator: Nora Terrault, MD
Phone: 415-476-8063
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1635 Divisadero Street
San Francisco, California 94110
Principal Investigator: Mandana Khalil, MD
Phone: 415-206-3725
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Santa Fe, New Mexico 87505
Principal Investigator: Joel N Gallant, MD
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Seattle, Washington 98101
(888) 862-2737
Principal Investigator: Alexander Kuo, MD
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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Valatie, New York 12184
Principal Investigator: Anathakrishnan Ramani, MD
Phone: 518-943-1943
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Washington, District of Columbia 20060
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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