NCT03623568撤回4 期
Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Undetectable HCV RNA in blood
研究概览
简要总结
This is a proof of concept, single center study for the donation of HCV-positive kidney to HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.
详细描述
The goal of this study is to determine if preoperative dosing and sustained administration of pan-genotypic DAA therapy after kidney transplantation prevents the transmission of hepatitis C virus (HCV) infection from an HCV positive donor kidney to an HCV naïve recipient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Met MGH transplant center criteria and already listed for kidney transplant
- •No available living kidney donor
- •Has ≤ 730 days (two years) of accrued transplant waiting time if blood type A and ≤ 1095 days of accrued transplant waiting time if blood type B or O.
- •On chronic hemodialysis or peritoneal dialysis or has a glomerular filtration rate <15mL/min/1.73m2 at the time of screening
- •Must agree to birth control. Women must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy and at least one barrier method
- •Weigh at least 50kg
- •Serum ALT within normal limits with no history of liver disease
- •Able to sign informed consent
排除标准
- •AB blood type
- •BMI > 35
- •Any liver disease in recipient
- •Pregnant or nursing (lactating) women
- •Known allergy or intolerance to tacrolimus that would require administration of cyclosporine rather than tacrolimus given the known drug-drug interaction between cyclosporine and Mavyret
- •Cardiomyopathy (LV ejection fraction < 50%)
- •Albumin < 3g/dl or platelet count < 75 x 103/mL
- •Positive donor specific antibodies or positive cross match deemed to be clinically relevant and increasing risk of rejection per the transplant surgeon or nephrologist
- •Positive donor specific antibodies or positive cross match deemed to be clinically relevant and increasing risk of rejection per the transplant surgeon or nephrologist
- •HCV RNA positive
- •Hepatitis B surface antigen positive
- •Any known liver disease or elevated liver transaminases
- •Patients with primary focal segmental glomerulosclerosis (FSGS), FSGS recurring after previous transplant, or disease process with increased risk of causing early graft failure as assessed by the transplant nephrologist and/or the investigator team
- •Any contra-indication to kidney transplantation per MGH center protocol
- •Patients on the following medications who cannot stop therapy: carbamazepine, rifampin, St. John's wort, and ethinyl estradiol-containing oral contraceptives.
研究组 & 干预措施
Treatment with Mavyret (glecaprevir/pibrentasvir) for HCV
Experimental
12 weeks of treatment with Mavyret
干预措施: glecaprevir/pibrentasvir tablets (Drug)
结局指标
主要结局
Undetectable HCV RNA in blood
时间窗: 12 weeks post treatment
Negative HCV viral RNA at 12 weeks after the last dose of treatment as determined by blood test
次要结局
- Safety (based on number of adverse events and out of range lab values) of DAA therapy in patients undergoing kidney transplantation)(12 weeks post treatment)
- Tolerability (based on number of adverse events and out of range lab values) of DAA therapy in patients undergoing kidney transplantation(12 Weeks post treatment)
研究者
Raymond T. Chung, MD
Director of Hepatology
Massachusetts General Hospital
研究点 (1)
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