NL-OMON50717尚未招募4 期
SUSTAINED RESPONSE TO NUCLEO(S)TIDE ANALOGUES FOR CHRONIC HEPATITIS B: SNAP STUDY - SNAP
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age 18 * 65 years
- •Treatment with entecavir or tenofovir
- •Previously HBeAg positive patients: stable HBeAg seroconversion (confirmed
- •HBeAg seroconversion at least 6 months apart) with at least 12 months of
- •subsequent consolidation therapy with HBV DNA <80 IU/mL
- •HBeAg negative patients: at least 3 years of continuous viral suppression (HBV
- •DNA <80 IU/mL)
- •Fibroscan value <7.0 at baseline
排除标准
- •* History of liver biopsy with advanced fibrosis or cirrhosis (F3 or F4)
- •* History of hepatic decompensation
- •* (history of) hepatocellular carcinoma
- •* Other active malignancy
- •* (planned) treatment with immunosuppressive agents
- •* (planned) pregnancy
- •* Coinfection with HIV, HCV, HDV
- •* Concomitant liver condition that may influence liver chemistry (such as
- •Gilbert*s syndrome). Defined as baseline ALT > 2x upper limit of normal, and/or
- •bilirubin > 1x upper limit of normal.
- •* Other indication for continued nucleo(s)tide analogue therapy
- •* Expected noncompliance to follow-up
- •* Treatment with medication that increases INR (such as vitamin K antagonists)
- •* Unwillingness to refrain from sexual activity without condom with partners
- •who are not vaccinated against hepatitis B virus
研究者
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