JPRN-jRCT2041200019进行中（未招募）2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of NPC-21 for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection - LionHeart21
Ichimaru Naotsugu0 个研究点目标入组 108 人开始时间: 2020年6月22日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •1.Male or female patients 18 to 75 years of age in the United States or 20 to 75 years of age in Japan.
- •2.Patients must be CMV seronegative pre-transplant and scheduled to receive or have received (within 7 days prior to first study drug administration) a first kidney transplant from a CMV seropositive donor.
- •3.Patients must be willing and able to give written informed consent for participation in the study.
- •4.Patients must be eligible to undergo kidney transplantation from a living or deceased donor, as per institutional standards.
- •5.Patients must agree with contraception by using appropriate contraceptive measures.
排除标准
- •1. Patients who have received a previous solid organ transplantation or
- •hematopoietic stem cell transplantation.
- •2. Patients who receive a multi-organ transplant.
- •3. Patients who have CMV disease or CMV viremia at Screening.
- •4. Patients who have a positive donor-specific antibody within 90 days
- •prior to Randomization confirmed via medical records.
- •5. Patients whose body weight is more than 120 kg at Screening.
- •6. Patients who have received the following anti-CMV therapy within 7 days
- •prior to Randomization and/or plan to receive the following anti-CMV therapy
- •during the study:
- •- Anti-CMV agents (eg, foscarnet, ganciclovir, valganciclovir, letermovir, high dose
- •acyclovir, high dose valacyclovir, high dose famciclovir, or cidofovir).
- •Note: The use of anti-CMV agents per local standard of care during the Rescue
- •Phase of the study is permitted.
- •7. Patients who have received the following therapy within 28 days prior to
- •Randomization and/or plan to receive the following anti-CMV therapy during the
- •- CMV hyperimmune globulin (eg, CytoGam).
- •- Intravenous immunoglobulin.
- •- Plasmapheresis (receipt prior to first study drug administration is acceptable).
- •8. Patients with a history of a serious drug allergy to proteins, immunoglobulins,
- •transfusions, or vaccines or any excipient of the NPC-21 formulation.
- •9. Patients with severe hepatic insufficiency at Screening (eg, Child-Pugh Class C).
- •10. Patients with active and untreated hepatitis B virus or hepatitis C virus, as
- •documented as part of the pre-transplant screening.
- •11. Patients with known human immunodeficiency virus infection, based on medical
- •records serology.
- •12. Patients with any uncontrolled infection at Randomization or a history of
- •serious and uncontrolled infection within 6 months prior to Randomization.
- •13. Patients who are pregnant or lactating.
- •14. Patients with a history of malignancy within 5 years prior to Randomization other
- •than curatively treated in situ cervical carcinoma, cutaneous basal cell carcinoma,
- •or cutaneous squamous cell carcinoma.
- •15. Patients with a history of alcohol or drug abuse or dependence within 1 year
- •prior to Randomization that, in the opinion of the Investigator, would preclude
- •study participation.
- •16. Patients who have previously participated in this study or any other study
- •involving NPC-21.
- •17. Patients who have previously participated or are currently participating in any
- •study involving the administration of a CMV vaccine or another CMV
- •investigational agent.
- •18. Patients who have participated in another interventional clinical study and
- •received another investigational product (ie, not approved by the Food and Drug
- •Administration in the United States or the Ministry of Health, Labour and Welfare
- •in Japan) within 90 days before Randomization.
- •19. Patients who are unable or unwilling, in the opinion of the Investigator, to comply
- •with the protocol.
研究者
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