NCT06299111已完成2 期
A Master Protocol for a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of REGN9933 and REGN7508, Monoclonal Antibodies Against Factor XI for Prevention of Venous Thromboembolism in Patients With a Peripherally Inserted Central Catheter (ROXI-CATH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 23
- 主要终点
- Incidence of confirmed VTE per central reading center (CRC) review
研究概览
简要总结
This study is researching 2 different experimental drugs called REGN9933 and REGN7508 (called "study drugs"). The study is focused on adults undergoing a placement of a catheter in the vein, also called a 'PICC line'.
The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related disease after catheter placement.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PICC is clinically indicated for at least 14 days and is anticipated to remain in place for at least 14 days
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 or equivalent functional status as described in the protocol
- •Body weight ≥45 kg and ≤130 kg during the screening period
- •International normalized ratio (INR) and aPTT values at or below the upper limit of normal as defined by the local lab during the screening period
- •Platelet count ≥100 x 10^9/L during the screening period as described in the protocol
排除标准
- •Unsuccessful PICC placement or any other complication associated with this procedure that in the opinion of the study investigator may present any safety concerns to the participant
- •History of prior venous thrombosis in the arm in which the PICC is to be placed
- •Peripheral catheter(s) in the same arm in which the PICC is to be placed or expected need for peripheral catheter(s) placement in the same arm the PICC is to be placed as described in the protocol
- •History of known thromboembolic disease or thrombophilia
- •Participants requiring therapeutic anticoagulation and/or antiplatelet therapy as described in the protocol
- •Expected to receive cancer therapy or other medication associated with a prior episode of Grade 4 thrombocytopenia as described in the protocol
- •Any history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, traumatic spinal or epidural anesthesia, or history of bleeding diathesis (such as but not limited to Hemophilia A or B, von Willebrand's disease, fibrinogen deficiency, and other inherited or acquired bleeding disorders) as described in the protocol
- •Note: Other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
Placebo
Placebo Comparator
Randomized 1:1:1
干预措施: Placebo (Drug)
REGN7508
Experimental
Randomized 1:1:1
干预措施: REGN7508 (Drug)
REGN9933
Experimental
Randomized 1:1:1
干预措施: REGN9933 (Drug)
结局指标
主要结局
Incidence of confirmed VTE per central reading center (CRC) review
时间窗: Through Day 14
Incidence of treatment-emergent adverse event (TEAEs)
时间窗: Up to Day 100
Severity of TEAEs
时间窗: Up to Day 100
次要结局
- Magnitude of ADA to REGN7508 over time(Up to Day 75)
- Incidence of confirmed PICC associated venous thrombosis per CRC review(Through Day 14)
- Incidence of major bleeding(Through Day 14)
- Incidence of clinically relevant non-major (CRNM) bleeding(Through Day 14)
- Concentrations of REGN9933 in serum(Up to Day 75)
- Concentrations of REGN7508 in serum(Up to Day 75)
- Change in activated partial thromboplastin time (aPTT)(Up to Day 75)
- Change in prothrombin time (PT)(Up to Day 75)
- Incidence of anti-drug antibody (ADA) to REGN9933 over time(Up to Day 75)
- Magnitude of ADA to REGN9933 over time(Up to Day 75)
- Incidence of ADA to REGN7508 over time(Up to Day 75)
研究者
研究点 (23)
Loading locations...
相似试验
进行中（未招募）
2 期
A Study to Test the Safety, Tolerability, and Efficacy of an Antibody, REGN7999, Injected Under the Skin for the Treatment of Iron Overload in Adult Participants With Non-Transfusion Dependent β-thalassemia, Using MRI Scans to Measure Iron Levels in the BodyNCT06421636Regeneron Pharmaceuticals19
已完成
3 期
A Study to Demonstrate How Well REGN1908-1909 Works in Reducing Ocular Allergy Signs and Symptoms in Adult Participants With Cat AllergyAllergic ConjunctivitisNCT06602726Regeneron Pharmaceuticals64
已完成
3 期
A Study to Demonstrate the Effect of REGN5713-5715 on Reducing Ocular Allergy Signs and Symptoms in Adult Participants With Birch Pollen AllergyAllergic ConjunctivitisNCT06602739Regeneron Pharmaceuticals54
已完成
2 期
A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult ParticipantsVenous ThromboembolismNCT06454630Regeneron Pharmaceuticals179
终止
2 期
REGN5381 in Adult Participants With Heart Failure With Reduced Ejection FractionHeart FailureNCT06237309Regeneron Pharmaceuticals89