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

Description

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.

Study Start Date

April, 20 2017

Estimated Completion Date

October 2018

Interventions

  • Drug: Ribavirin 200Mg Tablet
  • Drug: Glecaprevir/Pibrentasvir (G/P) 300mg/120mg

Study ID

University of Florida -- B16-439

Status

Recruiting

Trial ID

NCT03092375

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

225

Sponsor

University of Florida

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.

Gender

All

Ages

18 Years to 100 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (116)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Jenna Gustafson None None
Northwell Health Sandra Atlaas Bass Center for Liver Diseases - Manhasset, New York 172.2 miles Radica Palmer 516-562-2082 rpalmer@northwell.edu
Northwell Health Sandra Atlaas Bass Center for Liver Diseases - Manhasset, New York 172.2 miles Radica Palmer 516-562-2082 rpalmer@northwell.edu
Northwell Health Sandra Atlaas Bass Center for Liver Diseases - Manhasset, New York 172.2 miles Radica Palmer 516-562-2082 rpalmer@northwell.edu
Northwell Health Sandra Atlaas Bass Center for Liver Diseases - Manhasset, New York 172.2 miles Radica Palmer 516-562-2082 rpalmer@northwell.edu
Northwell Health Sandra Atlaas Bass Center for Liver Diseases - Manhasset, New York 172.2 miles Radica Palmer 516-562-2082 rpalmer@northwell.edu
Columbia University Medical Center - New York, New York 181.2 miles Ashley Rodriguez None ar3450@cumc.columbia.edu
Columbia University Medical Center - New York, New York 181.2 miles Ashley Rodriguez None ar3450@cumc.columbia.edu
Columbia University Medical Center - New York, New York 181.2 miles Ashley Rodriguez None ar3450@cumc.columbia.edu
Columbia University Medical Center - New York, New York 181.2 miles Ashley Rodriguez None ar3450@cumc.columbia.edu
Columbia University Medical Center - New York, New York 181.2 miles Ashley Rodriguez None ar3450@cumc.columbia.edu
Weill Cornell Medicine Hepatology - New York, New York 184.8 miles Raymond Peterson None rhp2003@med.cornell.edu
Weill Cornell Medicine Hepatology - New York, New York 184.8 miles Raymond Peterson None rhp2003@med.cornell.edu
Weill Cornell Medicine Hepatology - New York, New York 184.8 miles Raymond Peterson None rhp2003@med.cornell.edu
Weill Cornell Medicine Hepatology - New York, New York 184.8 miles Raymond Peterson None rhp2003@med.cornell.edu
Weill Cornell Medicine Hepatology - New York, New York 184.8 miles Raymond Peterson None rhp2003@med.cornell.edu
NYU Langone Medical Center - New York, New York 186.5 miles Therese Capobianco 212-263-0155 therese.capobianco@nyumc.org
NYU Langone Medical Center - New York, New York 186.5 miles Therese Capobianco 212-263-0155 therese.capobianco@nyumc.org
NYU Langone Medical Center - New York, New York 186.5 miles Therese Capobianco 212-263-0155 therese.capobianco@nyumc.org
University of PennsylvaniaPerelman Center for Advanced Medicine - Philadelphia, Pennsylvania 270.8 miles Kelly Borges 215-615-3755 kelly.borges@uphs.upenn.edu
University of PennsylvaniaPerelman Center for Advanced Medicine - Philadelphia, Pennsylvania 270.8 miles Kelly Borges 215-615-3755 kelly.borges@uphs.upenn.edu
University of PennsylvaniaPerelman Center for Advanced Medicine - Philadelphia, Pennsylvania 270.8 miles Kelly Borges 215-615-3755 kelly.borges@uphs.upenn.edu
University of PennsylvaniaPerelman Center for Advanced Medicine - Philadelphia, Pennsylvania 270.8 miles Kelly Borges 215-615-3755 kelly.borges@uphs.upenn.edu
University of PennsylvaniaPerelman Center for Advanced Medicine - Philadelphia, Pennsylvania 270.8 miles Kelly Borges 215-615-3755 kelly.borges@uphs.upenn.edu
The Johns Hopkins HospitalJohn G Bartlett Specialty Practice - Baltimore, Maryland 356.0 miles Stephanie Katz MSN RN None SSNEDDO2@JHMI.EDU
The Johns Hopkins HospitalJohn G Bartlett Specialty Practice - Baltimore, Maryland 356.0 miles Stephanie Katz MSN RN None SSNEDDO2@JHMI.EDU
The Johns Hopkins HospitalJohn G Bartlett Specialty Practice - Baltimore, Maryland 356.0 miles Stephanie Katz MSN RN None SSNEDDO2@JHMI.EDU
The Johns Hopkins HospitalJohn G Bartlett Specialty Practice - Baltimore, Maryland 356.0 miles Stephanie Katz MSN RN None SSNEDDO2@JHMI.EDU
The Johns Hopkins HospitalJohn G Bartlett Specialty Practice - Baltimore, Maryland 356.0 miles Stephanie Katz MSN RN None SSNEDDO2@JHMI.EDU
Digestive Disease Associates PA - Catonsville, Maryland 362.6 miles Shahi Seema 410-737-0053 s.shahi@ddamd.com
Digestive Disease Associates PA - Catonsville, Maryland 362.6 miles Shahi Seema 410-737-0053 s.shahi@ddamd.com
Digestive Disease Associates PA - Catonsville, Maryland 362.6 miles Shahi Seema 410-737-0053 s.shahi@ddamd.com
Digestive Disease Associates PA - Catonsville, Maryland 362.6 miles Shahi Seema 410-737-0053 s.shahi@ddamd.com
Digestive Disease Associates PA - Catonsville, Maryland 362.6 miles Shahi Seema 410-737-0053 s.shahi@ddamd.com
MedStar Health Research Institute - Washington, D.C., District of Columbia 391.7 miles Elliot Rozen 202-877-2136 elliot.n.rozen@medstar.net
Georgetown University Hospital - Washington, D.C., District of Columbia 394.4 miles Erica Christian None erica.christian@gunet.georgetown.edu
Bon Secours Liver Institute of Virginia - Richmond, Virginia 475.0 miles None None None
Bon Secours Liver Institute of Virginia - Richmond, Virginia 475.0 miles None None None
Bon Secours Liver Institute of Virginia - Richmond, Virginia 475.0 miles None None None
Bon Secours Liver Institute of Virginia - Richmond, Virginia 475.0 miles None None None
Bon Secours Liver Institute of Virginia - Richmond, Virginia 475.0 miles None None None
Duke University Medical Center - Durham, North Carolina 609.0 miles Loranda Ross 919-681-2941 loranda.ross@duke.edu
Duke University Medical Center - Durham, North Carolina 609.0 miles Loranda Ross 919-681-2941 loranda.ross@duke.edu
Duke University Medical Center - Durham, North Carolina 609.0 miles Loranda Ross 919-681-2941 loranda.ross@duke.edu
Duke University Medical Center - Durham, North Carolina 609.0 miles Loranda Ross 919-681-2941 loranda.ross@duke.edu
Duke University Medical Center - Durham, North Carolina 609.0 miles Loranda Ross 919-681-2941 loranda.ross@duke.edu
University of North Carolina at Chapel Hill - Chapel Hill, North Carolina 616.4 miles None None None
University of North Carolina at Chapel Hill - Chapel Hill, North Carolina 616.4 miles None None None
University of North Carolina at Chapel Hill - Chapel Hill, North Carolina 616.4 miles None None None
University of North Carolina at Chapel Hill - Chapel Hill, North Carolina 616.4 miles None None None
University of North Carolina at Chapel Hill - Chapel Hill, North Carolina 616.4 miles None None None
The Ohio State University - Columbus, Ohio 641.8 miles Hector Nava 614-685-8814 hector.nava@osumc.edu
The Ohio State University - Columbus, Ohio 641.8 miles Hector Nava 614-685-8814 hector.nava@osumc.edu
The Ohio State University - Columbus, Ohio 641.8 miles Hector Nava 614-685-8814 hector.nava@osumc.edu
The Ohio State University - Columbus, Ohio 641.8 miles Hector Nava 614-685-8814 hector.nava@osumc.edu
The Ohio State University - Columbus, Ohio 641.8 miles Hector Nava 614-685-8814 hector.nava@osumc.edu
Medical University of South Carolina - Charleston, South Carolina 821.2 miles Frank Beylotte 843-876-4273 beylott@musc.edu
Medical University of South Carolina - Charleston, South Carolina 821.2 miles Frank Beylotte 843-876-4273 beylott@musc.edu
Medical University of South Carolina - Charleston, South Carolina 821.2 miles Frank Beylotte 843-876-4273 beylott@musc.edu
Medical University of South Carolina - Charleston, South Carolina 821.2 miles Frank Beylotte 843-876-4273 beylott@musc.edu
Medical University of South Carolina - Charleston, South Carolina 821.2 miles Frank Beylotte 843-876-4273 beylott@musc.edu
Rush University Medical Center - Chicago, Illinois 851.3 miles Lelani Fetrow None lelani_c_fetrow@rush.edu
Atlanta Gastro Associates - Atlanta, Georgia 935.3 miles Anne Taylor RN 404-881-1094 ANNE.TAYLOR@ATLANTAGASTRO.COM
Atlanta Gastro Associates - Atlanta, Georgia 935.3 miles Anne Taylor RN 404-881-1094 ANNE.TAYLOR@ATLANTAGASTRO.COM
Atlanta Gastro Associates - Atlanta, Georgia 935.3 miles Anne Taylor RN 404-881-1094 ANNE.TAYLOR@ATLANTAGASTRO.COM
Atlanta Gastro Associates - Atlanta, Georgia 935.3 miles Anne Taylor RN 404-881-1094 ANNE.TAYLOR@ATLANTAGASTRO.COM
Atlanta Gastro Associates - Atlanta, Georgia 935.3 miles Anne Taylor RN 404-881-1094 ANNE.TAYLOR@ATLANTAGASTRO.COM
UF Health JacksonvilleGastroenterology Emerson - Jacksonville, Florida 1,020.2 miles Kelly Jackman None kelly.jackman@jax.ufl.edu
UF Health JacksonvilleGastroenterology Emerson - Jacksonville, Florida 1,020.2 miles Kelly Jackman None kelly.jackman@jax.ufl.edu
UF Health JacksonvilleGastroenterology Emerson - Jacksonville, Florida 1,020.2 miles Kelly Jackman None kelly.jackman@jax.ufl.edu
UF Health JacksonvilleGastroenterology Emerson - Jacksonville, Florida 1,020.2 miles Kelly Jackman None kelly.jackman@jax.ufl.edu
UF Health JacksonvilleGastroenterology Emerson - Jacksonville, Florida 1,020.2 miles Kelly Jackman None kelly.jackman@jax.ufl.edu
UF Hepatology Research at CTRB - Gainesville, Florida 1,081.3 miles PATRICK HORNE ARNP 352-273-9464 PATRICK.HORNE@MEDICINE.UFL.EDU
UF Hepatology Research at CTRB - Gainesville, Florida 1,081.3 miles PATRICK HORNE ARNP 352-273-9464 PATRICK.HORNE@MEDICINE.UFL.EDU
UF Hepatology Research at CTRB - Gainesville, Florida 1,081.3 miles PATRICK HORNE ARNP 352-273-9464 PATRICK.HORNE@MEDICINE.UFL.EDU
UF Hepatology Research at CTRB - Gainesville, Florida 1,081.3 miles PATRICK HORNE ARNP 352-273-9464 PATRICK.HORNE@MEDICINE.UFL.EDU
UF Hepatology Research at CTRB - Gainesville, Florida 1,081.3 miles PATRICK HORNE ARNP 352-273-9464 PATRICK.HORNE@MEDICINE.UFL.EDU
Orlando Immunology Center - Orlando, Florida 1,115.8 miles Jeffrey Dinsmore RN 407-409-7125 jdinsmore@oicorlando.com
Orlando Immunology Center - Orlando, Florida 1,115.8 miles Jeffrey Dinsmore RN 407-409-7125 jdinsmore@oicorlando.com
Orlando Immunology Center - Orlando, Florida 1,115.8 miles Jeffrey Dinsmore RN 407-409-7125 jdinsmore@oicorlando.com
Orlando Immunology Center - Orlando, Florida 1,115.8 miles Jeffrey Dinsmore RN 407-409-7125 jdinsmore@oicorlando.com
Orlando Immunology Center - Orlando, Florida 1,115.8 miles Jeffrey Dinsmore RN 407-409-7125 jdinsmore@oicorlando.com
Univ of Minnesota Health Clinics and Surgery Center Inc - Minneapolis, Minnesota 1,120.0 miles None None None
Univ of Minnesota Health Clinics and Surgery Center Inc - Minneapolis, Minnesota 1,120.0 miles None None None
Univ of Minnesota Health Clinics and Surgery Center Inc - Minneapolis, Minnesota 1,120.0 miles None None None
Univ of Minnesota Health Clinics and Surgery Center Inc - Minneapolis, Minnesota 1,120.0 miles None None None
Univ of Minnesota Health Clinics and Surgery Center Inc - Minneapolis, Minnesota 1,120.0 miles None None None
Southern Therapy and Advanced Research - Jackson, Mississippi 1,254.0 miles Evelyn Arendale None earendale@jacksonliverandgi.com
Southern Therapy and Advanced Research - Jackson, Mississippi 1,254.0 miles Evelyn Arendale None earendale@jacksonliverandgi.com
Southern Therapy and Advanced Research - Jackson, Mississippi 1,254.0 miles Evelyn Arendale None earendale@jacksonliverandgi.com
Schiff Center for Liver DiseasesUniversity of Miami - Miami, Florida 1,259.8 miles Sonia Carvalho 305-243-4639 None
Schiff Center for Liver DiseasesUniversity of Miami - Miami, Florida 1,259.8 miles Sonia Carvalho 305-243-4639 None
Schiff Center for Liver DiseasesUniversity of Miami - Miami, Florida 1,259.8 miles Sonia Carvalho 305-243-4639 None
Schiff Center for Liver DiseasesUniversity of Miami - Miami, Florida 1,259.8 miles Sonia Carvalho 305-243-4639 None
Schiff Center for Liver DiseasesUniversity of Miami - Miami, Florida 1,259.8 miles Sonia Carvalho 305-243-4639 None
Integris Baptist Medical Center - Oklahoma City, Oklahoma 1,495.7 miles Aquila Scott None aquila.scott@integrisok.com
Integris Baptist Medical Center - Oklahoma City, Oklahoma 1,495.7 miles Aquila Scott None aquila.scott@integrisok.com
Integris Baptist Medical Center - Oklahoma City, Oklahoma 1,495.7 miles Aquila Scott None aquila.scott@integrisok.com
Integris Baptist Medical Center - Oklahoma City, Oklahoma 1,495.7 miles Aquila Scott None aquila.scott@integrisok.com
Integris Baptist Medical Center - Oklahoma City, Oklahoma 1,495.7 miles Aquila Scott None aquila.scott@integrisok.com
University of Washington - Seattle, Washington 2,489.6 miles Peter Nguyen None HNGUYEN@MEDICINE.WASHINGTON.EDU
University of Washington - Seattle, Washington 2,489.6 miles Peter Nguyen None HNGUYEN@MEDICINE.WASHINGTON.EDU
University of Washington - Seattle, Washington 2,489.6 miles Peter Nguyen None HNGUYEN@MEDICINE.WASHINGTON.EDU
University of Washington - Seattle, Washington 2,489.6 miles Peter Nguyen None HNGUYEN@MEDICINE.WASHINGTON.EDU
University of Washington - Seattle, Washington 2,489.6 miles Peter Nguyen None HNGUYEN@MEDICINE.WASHINGTON.EDU
Virginia Mason Medical Center - Seattle, Washington 2,489.8 miles Kate Beck None kate.beck@virginiamason.org
Virginia Mason Medical Center - Seattle, Washington 2,489.8 miles Kate Beck None kate.beck@virginiamason.org
Virginia Mason Medical Center - Seattle, Washington 2,489.8 miles Kate Beck None kate.beck@virginiamason.org
Virginia Mason Medical Center - Seattle, Washington 2,489.8 miles Kate Beck None kate.beck@virginiamason.org
Virginia Mason Medical Center - Seattle, Washington 2,489.8 miles Kate Beck None kate.beck@virginiamason.org
Stanford University - Palo Alto, California 2,694.5 miles Pranali Suryavanshi 650-721-4288 pranali@stanford.edu
University of California San Francisco - San Francisco, California 2,699.8 miles Isaiah Thomas 415-476-5504 isaiah.thomas@ucsf.edu
University of California San Francisco - San Francisco, California 2,699.8 miles Isaiah Thomas 415-476-5504 isaiah.thomas@ucsf.edu
University of California San Francisco - San Francisco, California 2,699.8 miles Isaiah Thomas 415-476-5504 isaiah.thomas@ucsf.edu
University of California San Francisco - San Francisco, California 2,699.8 miles Isaiah Thomas 415-476-5504 isaiah.thomas@ucsf.edu
University of California San Francisco - San Francisco, California 2,699.8 miles Isaiah Thomas 415-476-5504 isaiah.thomas@ucsf.edu

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