Recruitment

Recruitment Status
Completed
Estimated Enrollment
175

Exclusion Criteria

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

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

Tracking Information

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