NCT02563665撤回不适用
A Prospective Study on Safety and Efficacy of Sofosbuvir Based Antiviral Regimen for Treating Hepatitis C in Patients With Moderate to Advanced Chronic Kidney Disease and Patients Receiving Renal Replacement Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Sustained Virologic Response 24 defined as HCV RNA <Lower Level of Qunatification 24 weeks after discontinuation of therapy.
研究概览
简要总结
All patients with chronic kidney disease (stages 3, 4 and 5) and chronic dialysis patients with HCV infection attending nephrology and Hepatology OPD or getting outpatient dialysis at the dialysis unit of ILBS.
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
- •Patients with moderate to severe renal dysfunction (CKD stage 3, 4, 5) and chronic dialysis patients
- •Patients consented for the study protocol by signing the informed consent.
排除标准
- •Age less than 18 years
- •Confirmed pregnancy
- •HCV-HIV Co infection
- •HBV-HCV co infection
结局指标
主要结局
Sustained Virologic Response 24 defined as HCV RNA <Lower Level of Qunatification 24 weeks after discontinuation of therapy.
时间窗: 1 year
次要结局
- number of adverse Events in both groups(2 years)
研究者
研究点 (1)
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