A Phase 2, Randomized, Open-Label Study to Evaluate theSafety and Efficacy of GS-4774 for the Treatment ofVirally-Suppressed Subjects with Chronic Hepatitis B
- Conditions
- Virally-Suppressed Subjects with Chronic Hepatitis BInfection - Other infectious diseases
- Registration Number
- ACTRN12613001080718
- Lead Sponsor
- Gilead Sciences, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 175
1. Documented evidence of chronic HBV infection (e.g., HBsAg positive for more than
6 months)
2. Virally-suppressed (screening HBV DNA <29 IU/mL) with HBV DNA below the lower
limit of quantification
3. Ability to understand and sign a writtent informed consent form, which must be obtained prior to initiation of study procedures
4. Currently taking an HBV oral antiviral medication
1. Cirrhosis
2. Co-infection with HCV, HIV or HDV
3. Evidence of hepatocellular carcinoma (e.g., as evidenced by recent imaging)
4. Significant cardiovascular, pulmonary, or neurological disease
5. Received solid organ or bone marrow transplant
6. Received prolonged therapy with immunomodulators (e.g., corticosteroids) or biologics
(e.g., monoclonal Ab, interferon) within 3 months of screening
7. Use of another investigational agents within 3 months of screening
8. Current alcohol or substance abuse judged by the investigator to potentially interfere with
subject compliance
9. Receipt of immunoglobulin or other blood products within 3 months of screening
10. Known hypersensitivity to study drug, metabolites or formulation excipients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method