TCTR20190609001招募中2 期
HBsAg seroclearance in non-cirrhotic, HBeAg-negative chronic hepatitis B patients who discontinue tenofovir or entecavir, prospective cohort study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 420
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 Years 至 100 Years（—）
- 性别
- All
入选标准
- •1. Age > 18 years old
- •2. Chronic hepatitis B eAg negative (ตั้งà¹à¸•à¹ˆà¹à¸£à¸à¸§à¸´à¸™à¸´à¸ˆà¸‰à¸±à¸¢)
- •3. On treatment of TDF or ETV at least 3 years
- •4. HBV DNA < 10 IU/ml at least 2 years before enrollment
- •5. No evidence of advanced fibrosis (Liver biopsy METAVIR > F3 )
- •6. No history of hepatic decompensation
- •7. CTP A (serum total bilirubin <2 mg/dl, serum albumin>3.5 mg/dl, INR <1.7)
- •8. CBC: Hemoglobin > 12 gm/dL, platelets > 100,000 mm3
排除标准
- •1. Transient elastography > 10 at least 6 months before enrollment
- •2. Creatinine clearance < 50
- •3. Poor compliance
- •4. Co-existing hepatocellular carcinoma or others malignancy
- •5. Co-existing with HIV or HCV infection
- •6. Pregnancy or breast feeding
- •7. Diagnosis of chronic liver disease from others etiology eg. AIH , Alcoholic liver disease
- •8.On immunosuppresive drugs or Post organ transplant
研究者
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