An Open-label, Non-randomized Pilot Study to Determine the Safety and Efficacy of Two Weeks of Fixed-dose Glecaprevir and Pibrentasvir as Pre- and Post-exposure Prophylactic Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Viral Response as Assessed by Number of Participants With Undetectable Hepatitis C RNA
研究概览
简要总结
In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time. Treatment will include glecaprevir 300 mg / pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant procedure and continued for 2 weeks post-renal transplant.
详细描述
In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time. Treatment will include glecaprevir 300 mg / pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant procedure and continued for 2 weeks post-renal transplant. The participant will continue to be tested for Hepatitis C for 12 weeks post-treatment.
The primary hypothesis is that prophylactic treatment with glecaprevir/pibrentasvir before and after transplant will prevent the establishment of HCV infection in the recipients of kidneys from HCV-infected deceased donors. Based on the success of preliminary studies, the objective of the study is to evaluate the safety and efficacy of 2 weeks of G-P as prophylaxis for HCV D+/R- kidney transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Participants ≥ 18 years old
- •On the deceased donor kidney waitlist at Johns Hopkins Hospital
- •Awaiting a first or second kidney transplant
- •No available living kidney donors
- •On hemodialysis or peritoneal dialysis or stage 5 chronic kidney disease (CKD) defined as a glomerular filtration rate <15 ml/min for ≥ past 90 days
- •HCV-uninfected (by both antibody and RNA PCR) and without any behavioral risk factors for contracting HCV other than being on hemodialysis
- •Calculated panel reactive anti-human leukocyte antigens (anti-HLA) antibody (flow cPRA) below 80%
排除标准
- •Plan to receive a multi-organ transplant
- •Plan to receive a dual kidney transplant (including en bloc)
- •History of prior solid organ transplant other than first kidney transplant
- •Participating in another study that involves an intervention or investigational product
- •Plan to receive a blood type incompatible kidney
- •History of human immunodeficiency (HIV), hepatitis C (HCV), or active hepatitis B (HBV) infection, defined as being on active antiviral treatment for HBV, detectable hepatitis B surface Ag or detectable hepatitis B DNA
- •Unable to safely substitute or discontinue a medication that is contraindicated with the study medication
- •Psychiatric or physical illness that in the opinion of the investigator would make it unsafe to proceed with transplantation or interfere with the ability of the subject to participate in the study
研究组 & 干预措施
Deceased donor HCV RNA PCR+
Participants who receive a kidney from HCV RNA PCR + deceased donor will receive glecaprevir/pibrentasvir 300 mg/120 mg once daily by mouth for 2 weeks
干预措施: Glecaprevir/pibrentasvir (Drug)
结局指标
主要结局
Viral Response as Assessed by Number of Participants With Undetectable Hepatitis C RNA
时间窗: 12 weeks after completing therapy
This is the number of participants with undetectable hepatitis C RNA in the blood at 12 weeks after stopping treatment (Number of kidney transplant recipients with HCV RNA \< Lower Limit Of Quantification (LLOQ)).
次要结局
未报告次要终点