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Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC) (ROXI-PEAK)

2026年7月6日 更新者：Regeneron Pharmaceuticals

A Master Protocol for a Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, for Prophylaxis of Venous Thromboembolism in Participants With a Peripherally Inserted Central Catheter (PICC) (ROXI-PEAK)

This study is researching 2 different experimental drugs called REGN7508 and REGN9933 (called "study drugs"). The study is focused on people who have a tube placed in a vein to receive treatment (called Peripherally Inserted Central Catheter [PICC]). Patients with PICCs have a higher risk of getting blood clots which can block the veins (this is called Venous Thromboembolism [VTE]) and lead to serious health problems or be life threatening.

The aim of the study is to see how well REGN7508 and REGN9933 prevent blood clots compared to placebo after PICC placement and to see if these medications cause certain types of bleeding.

The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drugs
  • How much study drug is in the blood at different times
  • Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)
  • If the study drugs affect the ability of the blood to clot normally

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

1908

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

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

不

描述

Key Inclusion Criteria:

  1. Is undergoing PICC placement for Intravenous (IV) administration of clinically indicated medications, including chemotherapy, antibiotics, TPN, and/or other indications as described in the protocol
  2. Has Eastern Cooperative Oncology Group Performance (ECOG) Status ≤3 or equivalent functional status as described in the protocol
  3. Has International Normalization Ratio (INR) and aPTT values no more than 25% above the upper limit as described in the protocol
  4. Weighs at least 40 kg during the screening period

Key Exclusion Criteria:

  1. Has a history of prior venous thrombosis in the arm and/or ipsilateral thoracic central veins in which the PICC is to be placed
  2. Has acute leukemia, myelodysplastic syndrome, or primary and secondary myelofibrosis
  3. Has unresected luminal gastrointestinal (GI) (including esophageal) or unresected genitourinary (GU) malignancy
  4. Has current or history of known brain tumors or brain metastases
  5. Has any major cardiovascular event within approximately the past 30 days prior to study administration
  6. Pre-existing central venous catheter or indwelling spinal or epidural catheter during the screening period

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂
药品：安慰剂
根据协议进行管理
实验性的：雷根7508
药品：Regn7508
根据协议管理
其他名称：
  • cenvacibart
实验性的：Regn9933
药品：Regn9933
根据协议管理
其他名称：
  • amrecibart

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Time-to-first event of centrally adjudicated VTE [symptomatic VTE or incidental VTE or asymptomatic VTE]
大体时间：Approximately 6 months
Approximately 6 months
Time-to-first event of centrally adjudicated International Society on Thrombosis and Haemostasis (ISTH)-defined major bleeding or Clinically Relevant Non-Major (CRNM) bleeding
大体时间：Approximately 6 months
Approximately 6 months

次要结果测量

结果测量
大体时间
Time-to-first event of centrally adjudicated symptomatic VTE [symptomatic Deep Vein Thrombosis (DVT) or symptomatic non-fatal Pulmonary Embolism (PE) or VTE-related death]
大体时间：Approximately 6 months
Approximately 6 months
Time-to-first event of symptomatic DVT
大体时间：Approximately 6 months
Approximately 6 months
Time-to-first event of symptomatic non-fatal PE
大体时间：Approximately 6 months
Approximately 6 months
Time-to-first event of VTE-related death
大体时间：Approximately 6 months
Approximately 6 months
Time-to-first event of incidental VTE
大体时间：Approximately 6 months
Approximately 6 months
Time-to-first event of incidental upper extremity or incidental proximal lower extremity DVT
大体时间：Approximately 6 months
Approximately 6 months
Time-to-first event of incidental PE (in a segmental or larger pulmonary artery)
大体时间：Approximately 6 months
Approximately 6 months
Time-to-first event of asymptomatic VTE (Asymptomatic DVT detected by upper extremity ultrasound)
大体时间：Approximately 6 months
Approximately 6 months
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
大体时间：Up to approximately 9 months
Up to approximately 9 months
Severity of TEAEs
大体时间：Up to approximately 9 months
Up to approximately 9 months
Concentrations of REGN7508
大体时间：Up to approximately 9 months
Up to approximately 9 months
Concentrations of REGN9933
大体时间：Up to approximately 9 months
Up to approximately 9 months
Change from baseline in activated Partial Thromboplastin Time (aPTT)
大体时间：Up to approximately 9 months
Up to approximately 9 months
Change from baseline in Prothrombin Time (PT)
大体时间：Up to approximately 9 months
Up to approximately 9 months
Occurrence of Anti-Drug Antibody (ADA) to REGN7508
大体时间：Up to approximately 9 months
Up to approximately 9 months
Magnitude of ADA to REGN7508
大体时间：Up to approximately 9 months
Up to approximately 9 months
Occurrence of ADA to REGN9933
大体时间：Up to approximately 9 months
Up to approximately 9 months
Magnitude of ADA to REGN9933
大体时间：Up to approximately 9 months
Up to approximately 9 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Regeneron Pharmaceuticals

调查人员

  • 研究主任：Clinical Trial Management、Regeneron Pharmaceuticals

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月20日

初级完成 (估计的)

2029年6月25日

研究完成 (估计的)

2029年9月21日

研究注册日期

首次提交

2026年7月6日

首先提交符合 QC 标准的

2026年7月6日

首次发布 (实际的)

2026年7月13日

研究记录更新

最后更新发布 (实际的)

2026年7月13日

上次提交的符合 QC 标准的更新

2026年7月6日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • R7508-DVT-25103
  • 2026-525288-42-00 (克蒂斯)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD 共享时间框架

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy

IPD 共享访问标准

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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.

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