Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B
A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of GS-4774 for the Treatment of Virally-Suppressed Subjects With Chronic Hepatitis B
1 other identifier
interventional
178
2 countries
17
Brief Summary
The primary objectives of this study are to evaluate the safety and efficacy of GS-4774 in adults with chronic hepatitis B (CHB) viral infection who have been virally suppressed with an oral antiviral (OAV) medication.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2013
Shorter than P25 for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2013
CompletedStudy Start
First participant enrolled
September 13, 2013
CompletedFirst Posted
Study publicly available on registry
September 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2015
CompletedResults Posted
Study results publicly available
November 1, 2019
CompletedNovember 1, 2019
October 1, 2019
12 months
September 12, 2013
October 3, 2019
October 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in HBsAg at Week 24
The change from baseline to Week 24 in HBsAg was analyzed using a mixed effect model for repeated measures (MMRM). The model included included treatment, HBsAg baseline level (≤ 1000 IU/mL or \> 1000 IU/mL), HBeAg baseline status (positive or negative), visit, and treatment-by-visit interaction as fixed effects and visit as a repeated measure.
Baseline; Week 24
Secondary Outcomes (7)
Change From Baseline in HBsAg at Week 12
Baseline; Week 12
Change From Baseline in HBsAg at Week 48
Baseline; Week 48
Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24
Week 24
Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48
Week 48
Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 24
Week 24
- +2 more secondary outcomes
Study Arms (4)
OAV Alone
EXPERIMENTALParticipants will continue their prebaseline OAV regimen alone from baseline to Week 48.
OAV + GS-4774 2 YU
EXPERIMENTALParticipants 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.
OAV + GS-4774 10 YU
EXPERIMENTALParticipants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 10 YU from baseline to Week 20.
OAV + GS-4774 40 YU
EXPERIMENTALParticipants will continue their prebaseline OAV regimen from baseline to Week 48, and will receive GS-4774 40 YU from baseline to Week 20.
Interventions
Administered as a subcutaneous injection every 4 weeks for a total of 6 doses
Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)
Eligibility Criteria
You may qualify if:
- Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
- 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)
You may not qualify if:
- Cirrhosis
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (17)
Dumont-UCLA Liver Transplant Center
Los Angeles, California, 90095, United States
Huntington Medical Research Institutes
Pasadena, California, 91105, United States
Kaiser Permanente
Sacramento, California, 95825, United States
Kaiser Permanente
San Diego, California, 92154, United States
Kaiser Permanente
San Francisco, California, 94118, United States
Silicon Valley Research Institute
San Jose, California, 95128, United States
University of Miami
Miami, Florida, 33136, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Digestive Disease Associates, PA
Baltimore, Maryland, 21229, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Hospital and Health System
Detroit, Michigan, 48202, United States
St.Louis University
St Louis, Missouri, 63104, United States
Medical Pro-care
Flushing, New York, 11355, United States
North Shore LIJ Health System
Manhasset, New York, 11030, United States
Bon Secours St. Mary's Hospital of Richmond
Newport News, Virginia, 23602, United States
Auckland Clinical Studies
Grafton, 1141, New Zealand
Related Publications (1)
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.
PMID: 27210427DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2013
First Posted
September 17, 2013
Study Start
September 13, 2013
Primary Completion
September 9, 2014
Study Completion
March 3, 2015
Last Updated
November 1, 2019
Results First Posted
November 1, 2019
Record last verified: 2019-10