Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Participants With Chronic Hepatitis B (CHB) and Who Are Currently Not on Treatment
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 175
Exclusion Criteria
- Known hypersensitivity to study drugs, metabolites or formulation excipients
- 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
- ...
- Known hypersensitivity to study drugs, metabolites or formulation excipients
- 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
- Receipt of immunoglobulin or other blood products within 3 months prior to enrollment
- Use of investigational agents within 3 months of screening
- Evidence of hepatocellular carcinoma (eg, as evidenced by recent imaging)
- History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease, Ulcerative colitis, or autoimmune disease
- Inadequate liver function
- Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, interferon) within 3 months of screening
- Current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance
- Received solid organ or bone marrow transplant
- Cirrhosis
- Documented history of yeast allergy
- Received antiviral treatment for HBV within 3 months of screening
- Significant cardiovascular, pulmonary, or neurological disease
- 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
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
- Known hypersensitivity to study drugs, metabolites or formulation excipients
- 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
- ...
- Known hypersensitivity to study drugs, metabolites or formulation excipients
- 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
- Receipt of immunoglobulin or other blood products within 3 months prior to enrollment
- Use of investigational agents within 3 months of screening
- Evidence of hepatocellular carcinoma (eg, as evidenced by recent imaging)
- History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease, Ulcerative colitis, or autoimmune disease
- Inadequate liver function
- Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, interferon) within 3 months of screening
- Current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance
- Received solid organ or bone marrow transplant
- Cirrhosis
- Documented history of yeast allergy
- Received antiviral treatment for HBV within 3 months of screening
- Significant cardiovascular, pulmonary, or neurological disease
- 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
Tracking Information
- NCT #
- NCT02174276
- Collaborators
- Not Provided
- Investigators
- Study Director: Gilead Study Director Gilead Sciences
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