Open-Label, Single Dose Study to Evaluate the Safety and Efficacy of Nivolumab With or Without GS 4774 for the Treatment of Chronic Hepatitis B patients who are currently receiving oral antiviral treatment

Phase 1

Completed

• Conditions: Chronic Hepatitis B; Infection - Other infectious diseases

• Registration Number: ACTRN12615001133527
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified