NCT03643172Unknown不适用
Termination of Nucleos(t)Ide Analogue Therapy of HBeAg Negative Chronic Hepatitis B - 2nd Register Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- HBsAg
研究概览
简要总结
All patients with chronic HBeAg negative hepatitis B treated with nucleos(t)ide analogues, who discontinue treatment based in the criteria outlined in the EASL hepatitis B guidelines shall be included in the present study. The aim is to evaluate the clinical outcome (virological relapse, HBsAg decline) and associated virological and immunological parameters.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients with chronic hepatitis B virus infection documented by detectable HBsAg.
- •Age > 18 years
- •Ongoing antiviral therapy with Entecavir or Tenofovir (TDF)
- •At least 3 years HBV-DNA < 20 IU/ml (=100 copies/ml)
- •HBeAg negative
- •Willingness to give written informed consent and willingness to participate and to comply with the protocol.
排除标准
- •HIV infection, persistent HDV-infection, persistent HCV infection
- •History or other evidence of a medical condition associated with chronic liver disease other than HBV associated (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures).
- •History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
- •Patients with advanced liver fibrosis and liver cirrhosis (fibroscan >10.0 kPa)
- •Patients with hepatocellular carcinoma
- •History of major organ transplantation or other immunosuppressive conditions
- •History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- •History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 12 months prior to cessation of antiviral therapy or the expectation that such treatment will be needed at any time during the study
结局指标
主要结局
HBsAg
时间窗: 48 weeks
HBsAg Change \> 1 log 48 weeks after stopping NA
次要结局
- Cytokine response(at every visit up to 96 weeks)
- Negativity for HBsAg(at every visit up to 96 weeks)
- Change in HBV RNA(at every visit up to 96 weeks)
- Chance in HBcrAg(at every visit up to 96 weeks)
- Virological relapse(at every visit up to 96 weeks)
- Biochemical relapse(at every visit up to 96 weeks)
- T cell response(at every visit up to 96 weeks)
- Retreatment(at every visit up to 48 weeks)
- timepoint of relapse(at every visit up to 96 weeks)
研究者
研究点 (1)
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