Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B
NCT ID: NCT01943799
Last Updated: 2019-11-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
178 participants
INTERVENTIONAL
2013-09-13
2015-03-03
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
TREATMENT
NONE
Study Groups
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OAV Alone
Participants will continue their prebaseline OAV regimen alone from baseline to Week 48.
OAV Regimen
Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)
OAV + GS-4774 2 YU
Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 2 yeast units (YU) from baseline to Week 20.
GS-4774
Administered as a subcutaneous injection every 4 weeks for a total of 6 doses
OAV Regimen
Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)
OAV + GS-4774 10 YU
Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 10 YU from baseline to Week 20.
GS-4774
Administered as a subcutaneous injection every 4 weeks for a total of 6 doses
OAV Regimen
Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)
OAV + GS-4774 40 YU
Participants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 40 YU from baseline to Week 20.
GS-4774
Administered as a subcutaneous injection every 4 weeks for a total of 6 doses
OAV Regimen
Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)
Interventions
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GS-4774
Administered as a subcutaneous injection every 4 weeks for a total of 6 doses
OAV Regimen
Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)
Eligibility Criteria
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Inclusion Criteria
* Currently taking an approved HBV oral antiviral medication
* Documented evidence of chronic HBV infection (eg, HBsAg positive for more than 6 months)
* Virally-suppressed (HBV DNA below the lower limit of quantification (LLOQ) for ≥ 1 year)
Exclusion Criteria
* Inadequate liver function
* Co-infection with hepatitic C virus (HCV), HIV or hepatitic D virus (HDV)
* Evidence of hepatocellular carcinoma
* Significant cardiovascular, pulmonary, or neurological disease
* Females who are pregnant or may wish to become pregnant during the study
* Received solid organ or bone marrow transplant
* Use of another investigational agents within 3 months of screening
* Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance
* History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease ulcerative colitis, autoimmune disease
* Known hypersensitivity to study drug, metabolites or formulation excipients
* Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Participants under evaluation for possible malignancy are not eligible.
18 Years
65 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Dumont-UCLA Liver Transplant Center
Los Angeles, California, United States
Huntington Medical Research Institutes
Pasadena, California, United States
Kaiser Permanente
Sacramento, California, United States
Kaiser Permanente
San Diego, California, United States
Kaiser Permanente
San Francisco, California, United States
Silicon Valley Research Institute
San Jose, California, United States
University of Miami
Miami, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Digestive Disease Associates, PA
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital and Health System
Detroit, Michigan, United States
St.Louis University
St Louis, Missouri, United States
Medical Pro-care
Flushing, New York, United States
North Shore LIJ Health System
Manhasset, New York, United States
Bon Secours St. Mary's Hospital of Richmond
Newport News, Virginia, United States
Auckland Clinical Studies
Grafton, , New Zealand
Countries
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References
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Lok AS, Pan CQ, Han SH, Trinh HN, Fessel WJ, Rodell T, Massetto B, Lin L, Gaggar A, Subramanian GM, McHutchison JG, Ferrari C, Lee H, Gordon SC, Gane EJ. Randomized phase II study of GS-4774 as a therapeutic vaccine in virally suppressed patients with chronic hepatitis B. J Hepatol. 2016 Sep;65(3):509-16. doi: 10.1016/j.jhep.2016.05.016. Epub 2016 May 19.
Other Identifiers
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GS-US-330-0101
Identifier Type: -
Identifier Source: org_study_id
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