2023-508603-21-00招募中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).
Regeneron Pharmaceuticals Inc.7 个研究点 分布在 3 个国家目标入组 93 人开始时间: 2024年8月12日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 93
- 试验地点
- 7
- 主要终点
- Incidence of confirmed VTE per central reading center (CRC) review
研究概览
简要总结
- Evaluate the efficacy of REGN9933 and REGN7508 individually, each compared to placebo, for prevention of venous thromboembolism (VTE) after peripherally inserted central catheter (PICC) placement.
- Assess the overall safety and tolerability of REGN9933 and REGN7508 individually.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 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
- •Other protocol defined inclusion criteria apply.
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.
- •Other protocol defined exclusion criteria apply.
结局指标
主要结局
Incidence of confirmed VTE per central reading center (CRC) review
Incidence of confirmed VTE per central reading center (CRC) review
Incidence and severity of treatment-emergent adverse events (TEAE)
Incidence and severity of treatment-emergent adverse events (TEAE)
次要结局
- Incidence of confirmed PICC-associated venous thrombosis per CRC review
- Incidence of major bleeding and clinically relevant non-major (CRNM) bleeding
- Concentrations of REGN9933
- Concentrations of REGN7508
- Change in activated partial thromboplastin time (aPTT) and in prothrombin time (PT)
- Incidence and magnitude of anti-drug antibodies (ADA) to REGN9933 over time
- Incidence and magnitude of ADA to REGN7508 over time
研究者
Medical Affairs
Scientific
Regeneron Pharmaceuticals Inc.
研究点 (7)
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