ACTRN12613001080718招募中2 期
A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of GS-4774 for the Treatment of Virally-Suppressed Subjects with Chronic Hepatitis B
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 175
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Documented evidence of chronic HBV infection (e.g., HBsAg positive for more than
- •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
排除标准
- •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
研究者
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