NCT01548820已完成不适用
Pretreatment and On-treatment Indicators of Virologic Breakthrough in Chronic HBV Egyptian Patients Receiving Lamivudine Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Resistance to Lamivudine Therapy
研究概览
简要总结
On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients
详细描述
Primarily: To study the correlations between the following parameters in adult Egyptian patients with chronic viral hepatitis B before treatment:
- ALT.
- HBeAg.
- HBV-DNA by quantitative PCR.
- Biopsy (if possible). Secondarily: After receiving lamivudine therapy we will identify the impact of these parameters on viral breakthrough at 1 year of therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients >18 years old
- •Egyptian nationality
- •Positive serology for HBsAg for more than 6 months
- •Positive HBV viremia (above 2000IU/ml).
- •Lamivudine monotherapy
排除标准
- •Anti-HBcIgM seropositivity
- •Positive serology for HCV
- •Positive serology for HDV
- •Patients complicated with HCC
结局指标
主要结局
Resistance to Lamivudine Therapy
时间窗: 1 year
Prevelance of Lamivudine resistance among HBV Egyptian cases pretreatment and on treatment parameters for Lamivudine therapy resistance
次要结局
未报告次要终点
研究者
Iman Fawzy Montasser
Lecturer of tropical medicine , Ain Shams university
Ain Shams University
研究点 (1)
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