NCT01944527Unknown不适用
Cohort of Liver Transplanted Patients With Hepatitis C Virus Recurrence and Treated With Direct-acting Antiviral Agents
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 699
- 试验地点
- 1
- 主要终点
- The rate of sustained virological response 12 weeks after discontinuation of direct-acting anti-HCV therapy in liver transplanted patients with HCV recurrence
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety and tolerability of direct-acting antivirals therapy in liver transplanted patients who experienced HCV recurrence.
This cohort is multicentric with constitution of biobank (plasma, serum) and the prospective collect of biological and clinical data's in the liver transplanted patients with recurrent HCV infection and treated with direct-acting anti-HCV agents.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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
- •Age > 18 years-old
- •Liver transplanted patient
- •Hepatitis C virus infection before transplantation
- •HCV recurrence with a detectable HCV RNA before enrollment in cohort
- •Use of at least one direct-acting antiviral agents with or without association with peginterferon and with or without association with ribavirin
- •Treated by direct-acting antiviral agents or has been yet completed the treatment but still on follow up
- •Affiliated to Health Insurance
- •Written Signed consent form
排除标准
- •Pregnant or breast-feeding female
结局指标
主要结局
The rate of sustained virological response 12 weeks after discontinuation of direct-acting anti-HCV therapy in liver transplanted patients with HCV recurrence
时间窗: 12 weeks after discontinuation of therapy
Sustained virological response (SVR) at 12 weeks after the end of the treatment (SVR defined as undetectable HCV RNA measured by PCR en real time at 12 weeks after antiviral therapy discontinuation)
次要结局
- Tolerability of direct acting antiviral HCV agents(Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatment and 4,12,24,48 weeks after treatment discontinuation)
- To evaluate emergence of viral resistance to direct-acting antivirals agents(Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatement and 4,12,24,48 weeks after treatment discontinuation)
- Evaluate the incidence of graft loss and acute rejection(Day 0, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatement and 4,12,24,48 weeks after treatment discontinuation)
- Virological responses at 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatment and 4,12,24,48 weeks after treatment discontinuation(Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatement and 4,12,24,48 weeks after treatment discontinuation)
- Drug-drug interactions(Baseline, 1,2,4,12,16, 24, 48 weeks during treatement and 4weeks after treatment discontinuation)
- To establish predictive factors of treatment failure and of emergence of viral resistance(Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatement and 4,12,24,48 weeks after treatment discontinuation)
- Impact on concomitant therapy on virological responses and safety(Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatment and 4,12,24,48 weeks after treatment discontinuation)
研究者
研究点 (1)
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