ISRCTN12811193已完成未知
HBsAg clearance in chronic hepatitis B patients with add-on pegylated interferon alpha 2a to ongoing tenofovir treatment: an open-label randomized controlled study
King Faisal Specialist Hospital and Research Centre0 个研究点目标入组 50 人开始时间: 2016年8月26日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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
- 性别
- All
入选标准
- •1. Male or female patients above 18 years of age
- •2. Chronic HBV patients receiving Tenofovir 300 mg orally daily for a minimum of 6 months
- •3. HBeAg-positive or HBeAg-negative patients
- •4. HBV DNA <2000 IU/ml before recruitment
- •5. HBsAg should be positive, and HBsAg titer should be measurable from the serum
排除标准
- •1. Side effects to medications or previous intolerance to Tenofovir or Peg IFN
- •2. Impaired renal function with a GFR <50
- •3. Hemoglobin <12 gm/L in women and <13 gm/L in men
- •4. Severe thrombocytopenia: platelets <75000
- •5. Neutropenia absolute neutrophil count (ANC)< 1000
- •6. Combined infection with HCV, HIV, HDV
- •7. Drug-induced, alcohol related or autoimmune liver disease
- •8. Patients with severe depression or other significant psychiatric illness
- •9. Previous history of lactic acidosis
- •10. Advanced cardiac, pulmonary, renal or neurological diseases
- •11. Liver cirrhosis with Child score (CTP) seven and above
- •12. Decompensated cirrhosis
- •13. Pregnancy and lactation
研究者
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