Multi-Center, Randomized, Open-Label Study of G/P +/- RBV for NS5A + SOF Previously Treated GT1 HCV Subjects
NCT ID: NCT03092375
Last Updated: 2020-02-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
177 participants
INTERVENTIONAL
2017-04-20
2020-02-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
About 75-90 non-cirrhotic subjects will be randomized in a 2:1 ratio to Arms A and B, and about 110-135 compensated cirrhotic subjects will be randomized in a 1:1 ratio to Arms C and D.
Non-cirrhotic subjects will be randomized 2:1 to:
1. Arm A: G/P 300 mg/120 mg Once a day for 12 weeks
2. Arm B: G/P 300 mg/120mg Once a day for 16 weeks
Subjects with compensated cirrhosis will be randomized 1:1 to:
3. Arm C: G/P 300 mg/120 mg QD + weight-based RBV (Ribavirin) Twice a day (1000 mg or 1200 mg total daily dose) for 12 weeks
4. Arm D: G/P 300 mg/120 mg QD for 16 weeks Retreatment sub-study Up to 11 subjects who still have hepatitis C virus after being treated in the Main study will have the option to enter the Retreatment sub-study and receive G/P plus Sofosbuvir and with or without RBV.
TREATMENT
NONE
Study Groups
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Arm A: G/P 300 mg/120 mg QD for 12 Wks
Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg (3 Glecaprevir/Pibrentasvir (G/P) 100mg/40mg Tablets once-daily by mouth) for 12 weeks.
Glecaprevir/Pibrentasvir (G/P) 300mg/120mg
daily
Arm B: G/P 300 mg/120 mg QD for 16 Wks
Non-cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once-daily by mouth for 16 weeks (G/P 300 mg/120 mg QD for 16 Wks)
Glecaprevir/Pibrentasvir (G/P) 300mg/120mg
daily
Arm C: G/P 300 mg/120 mg QD + RBV 12 Wks
Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily plus Ribavirin 200Mg Tablet (2-3 tablets) twice a day for 12 weeks (G/P 300 mg/120 mg QD + RBV 12 Wks)
Glecaprevir/Pibrentasvir (G/P) 300mg/120mg
daily
Ribavirin 200Mg Tablet
Weight-based 1000-1200 mg
Arm D: G/P 300 mg/120 mg QD for 16 Wks
Cirrhotic subjects will take Glecaprevir/Pibrentasvir (G/P) 300mg/120mg once daily for 16 weeks (G/P 300 mg/120mg QD for 16 Wks)
Glecaprevir/Pibrentasvir (G/P) 300mg/120mg
daily
Interventions
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Glecaprevir/Pibrentasvir (G/P) 300mg/120mg
daily
Ribavirin 200Mg Tablet
Weight-based 1000-1200 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
100 Years
ALL
No
Sponsors
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University of North Carolina, Chapel Hill
OTHER
AbbVie
INDUSTRY
University of Florida
OTHER
Responsible Party
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Principal Investigators
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David R Nelson, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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Stanford University
Palo Alto, California, United States
University of California, San Francisco
San Francisco, California, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
MedStar Health Research Institute
Washington D.C., District of Columbia, United States
UF Hepatology Research at CTRB
Gainesville, Florida, United States
UF Health Jacksonville-Gastroenterology Emerson
Jacksonville, Florida, United States
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Atlanta Medical Center
Atlanta, Georgia, United States
Atlanta Gastro Associates
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
The Johns Hopkins Hospital/John G. Bartlett Specialty Practice
Baltimore, Maryland, United States
Digestive Disease Associates, PA
Catonsville, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Univ. of Minnesota Health Clinics and Surgery Center, Inc.
Minneapolis, Minnesota, United States
Southern Therapy and Advanced Research
Jackson, Mississippi, United States
Northwell Health - Sandra Atlaas Bass Center for Liver Diseases
Manhasset, New York, United States
NYU Langone Medical Center
New York, New York, United States
Weill Cornell Medicine, Hepatology
New York, New York, United States
Columbia University Medical Center
New York, 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
The Ohio State University
Columbus, Ohio, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
University of Pennsylvania-Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Bon Secours Liver Institute of Virginia
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States
Countries
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References
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Wang GP, Schnell GL, Kort JJ, Sidhu GS, Schuster L, Tripathi RL, Larsen L, Michael LC, Bergquist K, Magee A, Patel CB, Whitlock JA, Tamashiro R, Peter JA, Fried MW, Nelson DR. Linkage of resistance-associated substitutions in GT1 sofosbuvir + NS5A inhibitor failures treated with glecaprevir/pibrentasvir. J Hepatol. 2021 Oct;75(4):820-828. doi: 10.1016/j.jhep.2021.04.057. Epub 2021 May 21.
Lok AS, Sulkowski MS, Kort JJ, Willner I, Reddy KR, Shiffman ML, Hassan MA, Pearlman BL, Hinestrosa F, Jacobson IM, Morelli G, Peter JA, Vainorius M, Michael LC, Fried MW, Wang GP, Lu W, Larsen L, Nelson DR. Efficacy of Glecaprevir and Pibrentasvir in Patients With Genotype 1 Hepatitis C Virus Infection With Treatment Failure After NS5A Inhibitor Plus Sofosbuvir Therapy. Gastroenterology. 2019 Dec;157(6):1506-1517.e1. doi: 10.1053/j.gastro.2019.08.008. Epub 2019 Aug 8.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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OCR16260
Identifier Type: OTHER
Identifier Source: secondary_id
B16-439
Identifier Type: -
Identifier Source: org_study_id
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