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
- History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease, Ulcerative colitis, or autoimmune disease
- Women who are pregnant or may wish to become pregnant during the course of the study
- Current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance
- ...
- History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease, Ulcerative colitis, or autoimmune disease
- Women who are pregnant or may wish to become pregnant during the course of the study
- Current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance
- 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
- Use of investigational agents within 3 months of screening
- Inadequate liver function
- Documented history of yeast allergy
- Evidence of hepatocellular carcinoma (eg, as evidenced by recent imaging)
- Receipt of immunoglobulin or other blood products within 3 months prior to enrollment
- Cirrhosis
- Received antiviral treatment for HBV within 3 months of screening
- Co-infection with hepatitis C virus (HCV), HIV or hepatitis D virus (HDV)
- Significant cardiovascular, pulmonary, or neurological disease
- Known hypersensitivity to study drugs, metabolites or formulation excipients
- Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, interferon) within 3 months of screening
- Received solid organ or bone marrow transplant
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
- History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease, Ulcerative colitis, or autoimmune disease
- Women who are pregnant or may wish to become pregnant during the course of the study
- Current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance
- ...
- History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease, Ulcerative colitis, or autoimmune disease
- Women who are pregnant or may wish to become pregnant during the course of the study
- Current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance
- 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
- Use of investigational agents within 3 months of screening
- Inadequate liver function
- Documented history of yeast allergy
- Evidence of hepatocellular carcinoma (eg, as evidenced by recent imaging)
- Receipt of immunoglobulin or other blood products within 3 months prior to enrollment
- Cirrhosis
- Received antiviral treatment for HBV within 3 months of screening
- Co-infection with hepatitis C virus (HCV), HIV or hepatitis D virus (HDV)
- Significant cardiovascular, pulmonary, or neurological disease
- Known hypersensitivity to study drugs, metabolites or formulation excipients
- Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, interferon) within 3 months of screening
- Received solid organ or bone marrow transplant
Tracking Information
- NCT #
- NCT02174276
- Collaborators
- Not Provided
- Investigators
- Study Director: Gilead Study Director Gilead Sciences
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