Clinical trial NCT01943799: Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic HBV Infection
Keywords: Hepatitis B (HBV)
Oral antiviral (OAV)
GS-4774
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-09-17
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

* 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)

Key Exclusion Criteria:

* 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in HBsAg at Week 24
timeFrame: Baseline; Week 24
Secondary outcomes:
measure: Change From Baseline in HBsAg at Week 12
timeFrame: Baseline; Week 12
measure: Change From Baseline in HBsAg at Week 48
timeFrame: Baseline; Week 48
measure: Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 24
timeFrame: Week 24
measure: Percentage of Participants With HBsAg Loss and HBsAg Seroconversion at Week 48
timeFrame: Week 48
measure: Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 24
timeFrame: Week 24
measure: Percentage of Participants With HBeAg Loss and HBeAg Seroconversion by Week 48
timeFrame: Week 48
measure: Percentage of Participants With a 1-log Decline in HBsAg by Weeks 12, 24, and 48
timeFrame: Baseline; Weeks 12, 24, and 48
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Dumont-UCLA Liver Transplant Center
state: California
city: Pasadena
country: United States
facility: Huntington Medical Research Institutes
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente
state: California
city: San Jose
country: United States
facility: Silicon Valley Research Institute
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Baltimore
country: United States
facility: Digestive Disease Associates, PA
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital and Health System
state: Michigan
city: Saint Louis
country: United States
facility: St.Louis University
state: Missouri
city: Flushing
country: United States
facility: Medical Pro-care
state: New York
city: Manhasset
country: United States
facility: North Shore LIJ Health System
state: New York
city: Newport News
country: United States
facility: Bon Secours St. Mary's Hospital of Richmond
state: Virginia
city: Grafton
country: New Zealand
facility: Auckland Clinical Studies
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: 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.