NCT04225923已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of NPC-21 for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection
Nobelpharma28 个研究点 分布在 2 个国家目标入组 87 人开始时间: 2020年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 28
- 主要终点
- Incidence of CMV Disease or CMV Viremia
研究概览
简要总结
The primary objective is to assess the efficacy and safety of NPC-21 when administered prophylactically to cytomegalovirus (CMV) seronegative patients receiving a first kidney transplant from a CMV seropositive donor.
详细描述
This is a Phase 2, randomized, double-blind, placebo-controlled study of NPC-21 for kidney transplant recipients at high risk of CMV infection in the United States and Japan. Approximately 108 eligible patients will be randomized prior to first study drug administration to receive low-dose NPC 21, high-dose NPC-21, or placebo. Randomization will be stratified by region (United States or Japan)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients 18 to 75 years of age in the United States or 20 to 75 years of age in Japan at the time of obtaining informed consent.
- •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.
- •Patients must be willing and able to give written informed consent for participation in the study.
- •Patients must be eligible to undergo kidney transplantation from a living or deceased donor, as per institutional standards.
- •Patients must agree with contraception by using appropriate contraceptive measures.
排除标准
- •Patients who have received a previous solid organ transplantation or hematopoietic stem cell transplantation.
- •Patients who receive a multi-organ transplant.
- •Patients who have CMV disease or CMV viremia at Screening.
- •Patients who have a positive donor-specific antibody within 90 days prior to Randomization confirmed via medical records.
- •Patients whose body weight is more than 120 kg at Screening.
- •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.
- •Note: The use of anti-herpes simplex virus and anti-varicella zoster virus prophylaxis for at-risk patients is recommended (as long as the doses are below the one specified above).
- •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 study:
- •CMV hyperimmune globulin (eg, CytoGam).
- •Intravenous immunoglobulin.
- •Plasmapheresis (receipt prior to first study drug administration is acceptable).
- •Patients with a history of a serious drug allergy to proteins, immunoglobulins, transfusions, or vaccines or any excipient of the NPC-21 formulation.
- •Patients with severe hepatic insufficiency at Screening (eg, Child-Pugh Class C).
- •Patients with active and untreated hepatitis B virus or hepatitis C virus, as documented as part of the pre-transplant screening.
- •Patients with known human immunodeficiency virus infection, based on medical records serology.
- •Patients with any uncontrolled infection at Randomization or a history of serious and uncontrolled infection within 6 months prior to Randomization.
- •Patients who are pregnant or lactating.
- •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.
- •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.
- •Patients who have previously participated in this study or any other study involving NPC-
- •Patients who have previously participated or are currently participating in any study involving the administration of a CMV vaccine or another CMV investigational agent.
- •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.
- •Patients who are unable or unwilling, in the opinion of the Investigator, to comply with the protocol.
研究组 & 干预措施
NPC-21 Low dose
Experimental
NPC-21 (6mg/kg) will be administered
干预措施: NPC-21 Low dose (Drug)
NPC-21 High dose
Experimental
NPC-21 (12mg/kg) will be administered
干预措施: NPC-21 High dose (Drug)
NPC-21 Placebo
Placebo Comparator
Placebo (normal saline) will be administered
干预措施: NPC-21 Placebo (Drug)
结局指标
主要结局
Incidence of CMV Disease or CMV Viremia
时间窗: 16 weeks
The proportion of patients with CMV disease (CMV syndrome or tissue-invasive CMV disease) or CMV viremia (defined as the detection of 250 IU/mL in plasma measured by PCR analysis in central laboratory or meets the local criteria for CMV viremia measured by PCR analysis or antigenemia testing) per total patients through 16 weeks from first study drug administration. The non-responders include all patients who develop CMV disease or CMV viremia and patients who discontinue from the study in the absence of CMV disease or CMV viremia.
次要结局
- Incidence of CMV Disease(28 weeks)
- Incidence of CMV Viremia(28 weeks)
- Time to Detectable CMV Viremia(28 weeks)
- Incidence of CMV Disease or CMV Viremia(28 weeks)
- Time to Detectable CMV Disease or CMV Viremia(28 weeks)
- Time to Detectable CMV Disease(28 weeks)
研究者
研究点 (28)
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