Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver and Post-Kidney Transplant (PRO-ACT:)
PRO-ACT: Prevention of De Novo HCV With Antiviral HCV Therapy Post-Liver
研究概览
地位
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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California
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San Francisco、California、美国、94143
- University of California, San Francisco
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Colorado
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Aurora、Colorado、美国、80045
- University of Colorado Denver
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Georgia
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Atlanta、Georgia、美国、30309
- Piedmont Research Institute
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New York
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New York、New York、美国、10032
- Columbia University
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Texas
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Dallas、Texas、美国、75246
- Baylor University Medical Center - Dallas
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Houston、Texas、美国、77030
- Houston Methodist Hospital
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adult (≥ 18 year-old), wait-listed for primary kidney or liver transplant without a potential suitable living donor or for simultaneous liver kidney transplant;
- HCV non-infected at the time of transplant. Subjects who were previously HCV infected but who have had documented SVR12 are eligible to participate;
- Agree to use two methods of birth control during the study;
- Donor characteristics: serum HCV NAT-positive and negative for hepatitis B surface antigen. For liver transplant: pre-donation liver biopsy with no fibrosis (F0) or minimal fibrosis (F1). For kidney transplant: kidney donor profile index < 85%.
Exclusion Criteria:
- Donor and/or recipient HIV infection
- Subject pregnant or nursing
- Donor and/or recipient Hepatitis B surface antigen positive
- Kidney-pancreas transplant
- Single organ liver recipients who received hemodialysis for more than 7 days prior to liver transplantation
- Kidney recipients: on dialysis for > 5 years at time of Screening; subjects sensitized with panel reactive antibody > 80%; for single organ kidney transplant, subjects with advanced liver fibrosis (Knodell stage 3) or cirrhosis
- Individuals being treated with and needing to continue rifabutin, rifampin, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, St. John's wort (Hypericum perforatum), medium- or high-dose rosuvastatin or atorvastatin, or high-dose proton pump inhibitors (See Concomitant Medications).
- Individuals treated with amiodarone within 42 days of organ transplant.
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Treatment Arm
Single Arm: Sofosbuvir/Velpatasvir Dosage: 400mg/100mg. Once daily for 12 weeks. |
Sofosbuvir/Velpatasvir starting early post-transplant for total of 12 weeks.
Only for patients who fail initial treatment with Sofosbuvir/Velpatasvir. Dosage: 400mg/100mg/100mg daily for 12 weeks. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Proportion of Participants With HCV RNA Level Below Limits of Quantification (LOQ)
大体时间:12 weeks after end of treatment
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The primary outcome was sustained virologic response, defined as HCV RNA below the lower limit of quantification 12 weeks after treatment completion (SVR12). Secondary outcomes included the proportion of patients with SVR24 defined as HCV RNA < lower limit of quantification 24 weeks after the end of treatment; with viral relapse defined as HCV RNA <LLOQ at end of treatment with subsequent quantifiable HCV RNA; and with on-treatment virologic breakthrough defined as > 1 log increase in viral RNA after treatment week 1. Safety was measured as the adverse events and serious adverse events attributed by the investigator to HCV infection or antiviral therapy; the proportion of recipients who prematurely discontinued antiviral therapy before the planned end of treatment; and patient and graft survival at 6 months post-transplant. |
12 weeks after end of treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Safety as Measured by the Proportion of Participants Who Prematurely Discontinue Antiviral Therapy Before the Planned End of Treatment
大体时间:12 weeks after start of treatment
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1 of 23 patients prematurely discontinued antiviral therapy due to intercurrent graft-versus-host disease that progressed to multiorgan failure.
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12 weeks after start of treatment
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Survival Rate of Patients and Their Allografts 6 Months Post Transplant
大体时间:6 months from time of liver transplant
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Graft and patient survival at 24 weeks after transplant
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6 months from time of liver transplant
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合作者和调查者
调查人员
- 首席研究员:Claus Niemann, MD、University of California, San Francisco
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
丙型肝炎的临床试验
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Meir Medical Center完全的开发从数字立体光盘图像测量 C/D 比的新技术 | C/D 测量的观察者内再现性 | C/D 测量的观察者间变异性
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University Hospital, GrenobleClinical Investigation Centre for Innovative Technology Network完全的
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University Hospital, Caen完全的
Sofosbuvir/Velpatasvir的临床试验
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Radboud University Medical Center撤销
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Peking University People's Hospital尚未招聘
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Instituto Nacional de Ciencias Medicas y Nutricion...Gilead Sciences尚未招聘物质使用者中的丙型肝炎
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Catherine Anne ChappellEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Gilead...完全的
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Catherine Anne ChappellGilead Sciences招聘中
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University of Maryland, BaltimoreGilead Sciences; Unity Health Care, Inc.完全的