Multi-Center, Randomized, Open-Label Study of G/P +/- RBV for NS5A + SOF Previously Treated GT1 HCV Subjects



Status:Enrolling by invitation
Conditions:Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 100
Updated:1/18/2019
Start Date:April 20, 2017
End Date:August 31, 2019

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A Phase 3b, Multi-Center, Randomized, Open-Label, Pragmatic Study of Glecaprevir/Pibrentasvir (G/P) +/- Ribavirin for GT1 Subjects With Chronic Hepatitis C Previously Treated With an NS5A Inhibitor + Sofosbuvir Therapy

The study will enroll well-compensated cirrhotic as well as non-cirrhotic subjects treatment
experienced with an NS5a Inhibitor + sofosbuvir and will include patients who did not
complete the prescribed duration due to adverse event or any reason other than for non/poor
compliance. Subjects will be randomized to 12 or 16 weeks of treatment.

The primary purpose of this study is to compare the efficacy and safety of glecaprevir and
pibrentasvir (G/P) for 12 weeks to G/P for 16 weeks in non-cirrhotic NS5A (non-structural
protein 5a)-inhibitor plus sofosbuvir ± RBV (Ribavirin) treatment-experienced adults with HCV
genotype 1 (GT1) infection, and to compare the efficacy and safety of G/P with RBV for 12
weeks to G/P without RBV for 16 weeks in NS5A-inhibitor plus sofosbuvir (SOF) ± RBV
treatment-experienced adults with compensated cirrhosis and GT1 infection.

Inclusion Criteria:

1. Male or female at least 18 years of age at time of screening.

2. A history of previous treatment with an NS5A-inhibitor plus sofosbuvir therapy ± RBV
for chronic HCV genotype 1 infection.

3. Treatment must have been completed at least 1 month prior to Screening Visit.

4. Screening laboratory result indicating chronic HCV GT1 infection. Subjects must be
able to understand and adhere to the study visit schedule and all other protocol
requirements and must voluntarily sign and date an informed consent.

Exclusion Criteria:

1. History of severe, life-threatening or other significant sensitivity to any drug.

2. Female who is pregnant, planning to become pregnant during the study or breastfeeding;
or male whose partner is pregnant or planning to become pregnant during the study.

3. Recent (within 6 months prior to study drug administration) history of drug or alcohol
abuse that could preclude adherence to the protocol in the opinion of the
investigator.

4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or
anti-human immunodeficiency virus antibody (HIV Ab) in patient without known history
of HIV infection.

5. HCV genotype performed during screening indicating co-infection with more than one HCV
genotype.

6. History or presence of liver decompensation.
We found this trial at
31
sites
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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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: Jama Darling, MD
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Charles Landis, MD
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 Lok, MD
Phone: 734-615-3853
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: 404-265-1044
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Atlanta, Georgia 30308
Principal Investigator: Norman Gitlin, MD
Phone: 404-881-1094
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1717 East Monument Street
Baltimore, Maryland 21287
Principal Investigator: Mark Sulkowski, MD
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Catonsville, Maryland 21228
Principal Investigator: Natarajan Ravendhran, MD
Phone: 410-737-0053
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Ira Willner, MD
Phone: 843-876-4273
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Nancy Reau, MD
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Sean Kelly, MD
Phone: 614-685-8814
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Gainesville, Florida 32610
Principal Investigator: David R Nelson, MD
Phone: 352-273-9464
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Jackson, Mississippi 39216
Principal Investigator: Brian Borg, MD
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4555 Emerson Street
Jacksonville, Florida 32207
Principal Investigator: Miguel Malespin, MD
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300 Community Drive
Manhasset, New York 11030
Principal Investigator: David E Bernstein, MD
Phone: 516-562-2082
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Miami, Florida 33136
Principal Investigator: Eugene Schiff, MD
Phone: 305-243-4639
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Minneapolis, Minnesota 55455
Principal Investigator: Mohamed Hassan, MD
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New York, New York 10016
Principal Investigator: James Park, MD
Phone: 212-263-0155
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525 East 68th Street
New York, New York 10021
Principal Investigator: Robert Brown, MD
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Elizabeth Verna, MD
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Oklahoma City, Oklahoma
Principal Investigator: Joykumar Patel, MD
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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: 650-721-4288
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Philadelphia, Pennsylvania 19104
Principal Investigator: Rajender Reddy, MD
Phone: 215-615-3755
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Richmond, Virginia 23226
Principal Investigator: Mitch Shiffman, MD
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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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San Francisco, California 94143
Principal Investigator: Norah Terrault, MD
Phone: 415-476-5504
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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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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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Washington, District of Columbia 20010
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