NCT07697599尚未招募3 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,908
- 主要终点
- Time-to-first event of centrally adjudicated VTE [symptomatic VTE or incidental VTE or asymptomatic VTE]
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Has Eastern Cooperative Oncology Group Performance (ECOG) Status ≤3 or equivalent functional status as described in the protocol
- •Has International Normalization Ratio (INR) and aPTT values no more than 25% above the upper limit as described in the protocol
- •Weighs at least 40 kg during the screening period
排除标准
- •Has a history of prior venous thrombosis in the arm and/or ipsilateral thoracic central veins in which the PICC is to be placed
- •Has acute leukemia, myelodysplastic syndrome, or primary and secondary myelofibrosis
- •Has unresected luminal gastrointestinal (GI) (including esophageal) or unresected genitourinary (GU) malignancy
- •Has current or history of known brain tumors or brain metastases
- •Has any major cardiovascular event within approximately the past 30 days prior to study administration
- •Pre-existing central venous catheter or indwelling spinal or epidural catheter during the screening period
- •Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
研究组 & 干预措施
REGN7508
Experimental
干预措施: REGN7508 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
REGN9933
Experimental
干预措施: REGN9933 (Drug)
结局指标
主要结局
Time-to-first event of centrally adjudicated VTE [symptomatic VTE or incidental VTE or asymptomatic VTE]
时间窗: 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
时间窗: Approximately 6 months
次要结局
- 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](Approximately 6 months)
- Time-to-first event of symptomatic DVT(Approximately 6 months)
- Time-to-first event of symptomatic non-fatal PE(Approximately 6 months)
- Time-to-first event of VTE-related death(Approximately 6 months)
- Time-to-first event of incidental VTE(Approximately 6 months)
- Time-to-first event of incidental upper extremity or incidental proximal lower extremity DVT(Approximately 6 months)
- Time-to-first event of incidental PE (in a segmental or larger pulmonary artery)(Approximately 6 months)
- Time-to-first event of asymptomatic VTE (Asymptomatic DVT detected by upper extremity ultrasound)(Approximately 6 months)
- Occurrence of Treatment-Emergent Adverse Events (TEAEs)(Up to approximately 9 months)
- Severity of TEAEs(Up to approximately 9 months)
- Concentrations of REGN7508(Up to approximately 9 months)
- Concentrations of REGN9933(Up to approximately 9 months)
- Change from baseline in activated Partial Thromboplastin Time (aPTT)(Up to approximately 9 months)
- Change from baseline in Prothrombin Time (PT)(Up to approximately 9 months)
- Occurrence of Anti-Drug Antibody (ADA) to REGN7508(Up to approximately 9 months)
- Magnitude of ADA to REGN7508(Up to approximately 9 months)
- Occurrence of ADA to REGN9933(Up to approximately 9 months)
- Magnitude of ADA to REGN9933(Up to approximately 9 months)
研究者
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