Recruitment

Recruitment Status
Completed
Estimated Enrollment
175

Exclusion Criteria

Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, interferon) within 3 months of screening
Evidence of hepatocellular carcinoma (eg, as evidenced by recent imaging)
Use of investigational agents within 3 months of screening
...
Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, interferon) within 3 months of screening
Evidence of hepatocellular carcinoma (eg, as evidenced by recent imaging)
Use of investigational agents within 3 months of screening
Women who are pregnant or may wish to become pregnant during the course of the study
Significant cardiovascular, pulmonary, or neurological disease
Inadequate liver function
Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Individuals under evaluation for possible malignancy are not eligible
Received solid organ or bone marrow transplant
Documented history of yeast allergy
Cirrhosis
Receipt of immunoglobulin or other blood products within 3 months prior to enrollment
Co-infection with hepatitis C virus (HCV), HIV or hepatitis D virus (HDV)
History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease, Ulcerative colitis, or autoimmune disease
Current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance
Known hypersensitivity to study drugs, metabolites or formulation excipients
Received antiviral treatment for HBV within 3 months of screening

Summary

Conditions
Chronic Hepatitis B
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Exclusion Criteria

Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, interferon) within 3 months of screening
Evidence of hepatocellular carcinoma (eg, as evidenced by recent imaging)
Use of investigational agents within 3 months of screening
...
Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, interferon) within 3 months of screening
Evidence of hepatocellular carcinoma (eg, as evidenced by recent imaging)
Use of investigational agents within 3 months of screening
Women who are pregnant or may wish to become pregnant during the course of the study
Significant cardiovascular, pulmonary, or neurological disease
Inadequate liver function
Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Individuals under evaluation for possible malignancy are not eligible
Received solid organ or bone marrow transplant
Documented history of yeast allergy
Cirrhosis
Receipt of immunoglobulin or other blood products within 3 months prior to enrollment
Co-infection with hepatitis C virus (HCV), HIV or hepatitis D virus (HDV)
History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease, Ulcerative colitis, or autoimmune disease
Current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance
Known hypersensitivity to study drugs, metabolites or formulation excipients
Received antiviral treatment for HBV within 3 months of screening

Locations

Palo Alto, California
Vancouver, British Columbia
Philadelphia, Pennsylvania
Auckland
Parma
...
Palo Alto, California
Vancouver, British Columbia
Philadelphia, Pennsylvania
Auckland
Parma
Yangsan
Seoul
Toronto, Ontario
Seoul
Daegu
Sacramento, California
Yangsan
San Jose, California
Seongnam
Seoul
Bucharest
Winnipeg, Manitoba
San Giovanni Rotondo
San Francisco, California
New York, New York
Toronto, Ontario
Richmond, Virginia
Toronto, Ontario
Pisa
Vancouver, British Columbia
Seocho
Bologna
San Diego, California
Springfield, Virginia
Baltimore, Maryland
Boston, Massachusetts
Bucharest
Honolulu, Hawaii

Tracking Information

NCT #
NCT02174276
Collaborators
Not Provided
Investigators
Study Director: Gilead Study Director Gilead Sciences