NL-OMON49813招募中不适用
Prospective study on peripheral and intrahepatic immune cells derived from chronic hepatitis B patients during and after long-term treatment with direct antivirals - HBV-FNAB-002 study
Stichting Leveronderzoek0 个研究点目标入组 7 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 7
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- man or woman, age of ><=18 and <<= 70 years
- •- chronic Hepatitis B (HBsAg positive for minimum 6 months)
- •- > 3 years on treatment with direct antivirals for CHB
- •- HBV DNA undetectable or < 60 IU/mL, on NA treatment for minimal 2 years
- •- HBeAg negative, while on NA treatment for minimal 2 year
- •- ALT < 1.5 ULN (by local assay), while on NA treatment for minimal 1 year and
- •at screening
- •- no evidence of cirrhosis
- •- HBV Genotype A, B, C, D or E
- •- otherwise healthy and medically stable
- •- written informed consent
排除标准
- •- positive HIV test
- •- hepatitis A, C, D or E co-infection
- •- Subject had severe hepatitis activity (ALT >= 10xULN) while on NA(s)
- •treatment 2years before screening, or elevation ALT Level>1xULN 1 year before
- •screening and at screening
- •- decompensated cirrhosis or hepatocellular carcinoma (documented medical
- •- Subject has an underlying condition which preclude the choice of direct
- •antivirals as treatment
- •- participation in another translational research study
- •- use of any investigational drug or use of an invasive investigational medical
- •device within 90 days before screening
- •- Subject has received immuno-modulating drugs (within 18 months prior to
- •screening) for HBV
- •- any condition for which, in the opinion of the investigator, participation
- •would not be in the best interest of the subject
- •- major surgery (e.g. requiring general anaesthesia) within 12 weeks before
- •- history of drug or alcohol abuse within 1 year before screening
- •- divers lab parameters (platelets, INR, bilirubin, Hb, eGFR, AFP)
- •- anticoagulation therapy or bleeding diathesis
- •- hemoglobinopathy
- •- pregnancy or breast-feeding
研究者
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