Text Size

Open-Label Study of GS-7977+ Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

This study is currently recruiting participants.
Verified April 2013 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01625338
First received: June 7, 2012
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  Purpose

Open label study of GS-7977 in combination with ribavirin (RBV) with or without Peginterferon Alfa-2a (PEG) in adults with chronic HCV who participated in a prior Gilead HCV study and have not achieved SVR.


Condition Intervention Phase
Chronic Hepatitis C
 Drug: GS-7977 in combination with ribavirin
Drug: GS-7977 400mg QD+ RBV BID+ PEG
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study of GS-7977 + Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Efficacy 12 weeks post dosing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The proportion of patients with a sustained virologic response (SVR) 12 weeks after discontinuation of therapy

  • Safety and tolerability of GS-7977 + RBV with or without PEG as measured by review of the accumulated safety data. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    The safety and tolerability of GS-7977 + RBV with or without PEG as measured by review of the accumulated safety data


Secondary Outcome Measures:
  • Efficacy 4 and 24 weeks post dosing [ Time Frame: 4 and 24 weeks ] [ Designated as safety issue: No ]
    To determine the proportion of subjects who attain SVR at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24)

  • Amount of plasma HCV RNA [ Time Frame: 12 weeks post dosing ] [ Designated as safety issue: No ]
    To evaluate the kinetics of plasma HCV RNA during treatment and after treatment discontinuation

  • Characterization of viral resistance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To evaluate the emergence of viral resistance to GS 7977 during treatment and after treatment discontinuation


Estimated Enrollment: 600
Study Start Date: June 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GS-7977 400 mg QD + RBV BID for 12 weeks Drug: GS-7977 in combination with ribavirin
GS 7977 400 mg QD + RBV BID
Experimental: GS-7977 400 mg QD + RBV BID for 24 weeks Drug: GS-7977 in combination with ribavirin
GS 7977 400 mg QD + RBV BID
Experimental: GS-7977 400 mg QD + RBV BID + PEG (180 μg/week) for 12 weeks Drug: GS-7977 400mg QD+ RBV BID+ PEG

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infection with HCV
  • Must have participated in a prior Gilead HCV study
  • Use of highly effective contraception methods if female of childbearing potential or sexually active male
  • Eligible patients include those in the following categories:
  • received placebo or PEG+RBV in a control arm

  • previously participated in a Gilead-sponsored HCV study and did not attain SVR24 on a regimen containing:

    • GS-7977+RBV
    • PEG and/or RBV in combination with one or more Gilead investigational direct acting agents

Exclusion Criteria:

  • Pregnant or nursing female or male with pregnant female partner
  • Current or prior history of clinical hepatic decompensation
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Chronic use of systemically administered immunosuppressive agents
  • Active drug abuse
  • Use of any prohibited concomitant medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01625338

Contacts
Contact: Teresa Stondell 7977Phase3@gilead.com

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
United States, California
Franco Felizarta, MD Recruiting
Bakersfield, California, United States, 93301
Arrowhead Regional Medical Center Recruiting
Colton, California, United States, 92324
Southern California Transplantation Institute, Research Foundation Liver Center Recruiting
Coronado, California, United States, 92118
eStudySite Recruiting
La Mesa, California, United States, 91942
eStudy Site Recruiting
La Mesa, California, United States, 91942
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Anthony Mills MD, Inc. Recruiting
Los Angeles, California, United States, 90069
Kaiser Permanente Recruiting
Los Angeles, California, United States, 90027
Lightsource Medical/Peter J. Ruane MD, Inc. Recruiting
Los Angeles, California, United States, 90036
eStudySite Recruiting
Oceanside, California, United States, 92056
University of California Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Kaiser Permanente Recruiting
San Diego, California, United States, 92154
Medical Associates Research Group Recruiting
San Diego, California, United States, 92123
University of California Recruiting
San Diego, California, United States, 92103
Quest Clinical Research Recruiting
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
South Denver Gastroenterology, PC Recruiting
Englewood, Colorado, United States, 80113
United States, District of Columbia
Whitman-Walker Health Recruiting
Washington, District of Columbia, United States, 20009
United States, Florida
Pointe West Infectious Diseases d/b/a Bach and Godofsky Infectious Diseases Recruiting
Bradenton, Florida, United States, 34209
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Borland-Groover Clinic Recruiting
Jacksonville, Florida, United States, 32256
University of Miami Center for Liver Diseases Recruiting
Miami, Florida, United States, 33136
Orlando Immunology Center Recruiting
Orlando, Florida, United States, 32803
Internal Medicine Specialists Recruiting
Orlando, Florida, United States, 32806
Advanced Research Institute Recruiting
Trinity, Florida, United States, 34655
South Florida Center of Gastroenterology, PA. Recruiting
Wellington, Florida, United States, 33414
United States, Georgia
Atlanta Gastroenterology Associates, LLC Recruiting
Atlanta, Georgia, United States, 30308
Digestive Healthcare of Georgia Recruiting
Atlanta, Georgia, United States, 30309
Gastointestinal Specialists of Georgia, PC Recruiting
Marietta, Georgia, United States, 30060
United States, Indiana
Indianapolis Gastroenterology Research Foundation Recruiting
Indianapolis, Indiana, United States, 46237
United States, Maryland
Digestive Disease Associates, PA Recruiting
Baltimore, Maryland, United States, 21229
Johns Hopkins University Recruiting
Lutherville, Maryland, United States, 21093
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Infectious Disease and The Research Institute Recruiting
Springfield, Massachusetts, United States, 01105
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
United States, Minnesota
Minnesota Gastroenterology, P.A. Recruiting
St. Paul, Minnesota, United States, 55114
United States, Missouri
Kansas City Gastroenterology and Hepatology Recruiting
Kansas City, Missouri, United States, 64131
United States, New Jersey
ID Care, Inc. Recruiting
Hillsborough, New Jersey, United States, 08844
AGA Clinical Research Associates, LLC Recruiting
Township, New Jersey, United States, 08234
The Gastroenterology Group of South Jersey Recruiting
Vineland, New Jersey, United States, 08360
United States, New York
Binghamton Gastroenterology Associates, PC Recruiting
Binghamton, New York, United States, 13903
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
United States, North Carolina
Clinical Study Center of Asheville, LLC Recruiting
Asheville, North Carolina, United States, 28801
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Carolinas Center for Liver Disease Recruiting
Statesville, North Carolina, United States, 28677
Digestive Health Specialists, PA Recruiting
Winston Salem, North Carolina, United States, 27103
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15261
United States, Rhode Island
University Gastroenterology Recruiting
Providence, Rhode Island, United States, 02905
United States, Tennessee
Gastro One Recruiting
Germantown, Tennessee, United States, 38138
Nashville Medical Research Institute Recruiting
Nashville, Tennessee, United States, 37211
United States, Texas
Texas Clinical Research Institute, LLC Recruiting
Arlington, Texas, United States, 76012
Annette C. and Harold C. Simmons Transplant Center Recruiting
Dallas, Texas, United States, 75246
Research Specialists of Texas Recruiting
Houston, Texas, United States, 77030
Alamo Medical Research Recruiting
San Antonio, Texas, United States, 78215
United States, Virginia
Metropolitan Research Recruiting
Fairfax, Virginia, United States, 22031
Inova Fairfax Hospital Recruiting
Falls Church, Virginia, United States, 22042
Bon Secours Saint Mary's Hospital of Richmond Recruiting
Newport News, Virginia, United States, 23602
Digestive and Liver Disease Specialists Recruiting
Norfolk, Virginia, United States, 23502
Bon Secours St. Mary's Hospital of Richmond, Inc. (referred to as St. Mary's) Recruiting
Richmond, Virginia, United States, 23226
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98111
Australia, Queensland
Gallipoli Medical Research Foundation Recruiting
Greenslopes, Queensland, Australia, 4120
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Austin Hospital Recruiting
Heidelberg, Victoria, Australia, 3084
Monash Medical Centre Recruiting
Melbourne, Victoria, Australia, 3168
Australia
St. Vincent's Hospital Recruiting
Fitzroy, Australia, 3065
Royal Brisbane & Women's Hospital Recruiting
Herston, Australia, QLD 4029
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Canada, British Columbia
Gastrointestinal Research Institute (GIRI) Recruiting
Vancouver, British Columbia, Canada, V6Z 2K5
Gordon & Leslie Diamond Health Care Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Toronto Liver Centre Recruiting
Toronto, Ontario, Canada, M6H 3M1
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Hopital St. Luc Recruiting
Montreal, Quebec, Canada, H2X 3J4
Germany
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Italy
Casa Sollievo della Sofferenza Hospital Recruiting
San Giovanni Rotonda, Foggia, Italy, 71013
New Zealand
Auckland Clinical Studies Recruiting
Grafton, Auckland, New Zealand, 1010
Tauranga Hospital Recruiting
Tauranga, BOP, New Zealand, 3143
Wellington Hospital Recruiting
Newtown, WGN, New Zealand, 6021
Auckland City Hospital Recruiting
Auckland, New Zealand, 11142
Christchurch Hospital Recruiting
Christchurch, New Zealand, 8011
Dunedin Hospital Recruiting
Dunedin, New Zealand, 9016
Waikato Hospital Recruiting
Hamilton, New Zealand, 3240
Puerto Rico
Fundacion De Investigacion De Diego Recruiting
San Juan, Puerto Rico, 927
Spain
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 8035
Hospital Carlos III Recruiting
Madrid, Spain, 28029
Sweden
Skånes Universitetssjukhus, Malmö Recruiting
Malmo, Sweden, 20502
United Kingdom
Nottingham University Hospitals-NHS Recruiting
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01625338     History of Changes
Other Study ID Numbers: GS-US-334-0109
Study First Received: June 7, 2012
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
HCV genotype 2 (GT-2)
HCV genotype 3 (GT-3)
HCV
Sustained Virologic Response
Direct Acting Antiviral
 Combination Therapy
GS-7977
Ribavirin
Open Label

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013