ACTRN12615001133527CompletedPhase 1
A Phase 1, Open-Label, Single Dose Study to Evaluate the Safety and Efficacy of Nivolumab With or Without GS 4774 for the Treatment of Virally Suppressed Subjects with Chronic Hepatitis B
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Gilead Sciences, Inc.
- Enrollment
- 24
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to 65 Years (—)
- Sex
- All
Inclusion Criteria
- •1. Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study
- •2. Documented evidence of chronic HBV infection (e.g., HBsAg positive for more than 6 months)
- •3. Must be HBeAg negative at screening
- •4. Have been receiving approved HBV oral antiviral treatment for greater than/equal to 1 year prior to screening
- •5. A negative serum pregnancy test is required for female subjects (unless surgically sterile or greater than two years post-menopausal)
- •6. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Exclusion Criteria
- •1. Cirrhosis
- •2. Inadequate liver function
- •3. Co-infection with hepatitis C virus (HCV), HIV or hepatitis D virus (HDV)
- •4. Evidence of hepatocellular carcinoma (e.g., as evidenced by recent imaging)
- •5. Presence of active infections
- •6. Women who are pregnant or may wish to become pregnant during the course of the study
- •7. Received solid organ or bone marrow transplant
- •8. Received prolonged therapy with immunomodulators (e.g., corticosteroids) or biologics (e.g., monoclonal Ab,
- •interferon) within 3 months of screening
- •9. Use of investigational agents within 3 months of screening
- •10. Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance
- •11. History of significant autoimmune disease
- •12. Documented history of yeast allergy
- •13. Known hypersensitivity to study drugs, metabolites or formulation excipients
- •14. Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical
- •resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible
Investigators
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