Recruitment

Recruitment Status
Completed
Estimated Enrollment
175

Exclusion Criterias

Evidence of hepatocellular carcinoma (eg, as evidenced by recent imaging)
Documented history of yeast allergy
Receipt of immunoglobulin or other blood products within 3 months prior to enrollment
...
Evidence of hepatocellular carcinoma (eg, as evidenced by recent imaging)
Documented history of yeast allergy
Receipt of immunoglobulin or other blood products within 3 months prior to enrollment
Inadequate liver function
Co-infection with hepatitis C virus (HCV), HIV or hepatitis D virus (HDV)
Women who are pregnant or may wish to become pregnant during the course of the study
Received antiviral treatment for HBV within 3 months of screening
Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, interferon) within 3 months of screening
History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease, Ulcerative colitis, or autoimmune disease
Cirrhosis
Significant cardiovascular, pulmonary, or neurological disease
Use of investigational agents within 3 months of screening
Known hypersensitivity to study drugs, metabolites or formulation excipients
Received solid organ or bone marrow transplant
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
Current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance

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 Criterias

Evidence of hepatocellular carcinoma (eg, as evidenced by recent imaging)
Documented history of yeast allergy
Receipt of immunoglobulin or other blood products within 3 months prior to enrollment
...
Evidence of hepatocellular carcinoma (eg, as evidenced by recent imaging)
Documented history of yeast allergy
Receipt of immunoglobulin or other blood products within 3 months prior to enrollment
Inadequate liver function
Co-infection with hepatitis C virus (HCV), HIV or hepatitis D virus (HDV)
Women who are pregnant or may wish to become pregnant during the course of the study
Received antiviral treatment for HBV within 3 months of screening
Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, interferon) within 3 months of screening
History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease, Ulcerative colitis, or autoimmune disease
Cirrhosis
Significant cardiovascular, pulmonary, or neurological disease
Use of investigational agents within 3 months of screening
Known hypersensitivity to study drugs, metabolites or formulation excipients
Received solid organ or bone marrow transplant
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
Current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance

Locations

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

Tracking Information

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