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Набор скоро начнётся NCT07697599

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

Фаза III С лечением Venous Thromboembolism (VTE)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: REGN7508, REGN9933, Placebo.
Кому может быть актуально
Состояния в реестре: Venous Thromboembolism (VTE). Базовые параметры: от 15 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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)

Обзор

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

Вмешательства

  • Препарат REGN7508
    Administered per the protocol
  • Препарат REGN9933
    Administered per the protocol
  • Препарат Placebo
    Administered per the protocol

Первичные конечные точки

  • Time-to-first event of centrally adjudicated VTE [symptomatic VTE or incidental VTE or asymptomatic VTE] [Срок оценки: 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 [Срок оценки: Approximately 6 months]
Вторичные конечные точки (12)
  • 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] [Срок оценки: Approximately 6 months]
  • Time-to-first event of symptomatic DVT [Срок оценки: Approximately 6 months]
  • Time-to-first event of symptomatic non-fatal PE [Срок оценки: Approximately 6 months]
  • Time-to-first event of VTE-related death [Срок оценки: Approximately 6 months]
  • Time-to-first event of incidental VTE [Срок оценки: Approximately 6 months]
  • Time-to-first event of incidental upper extremity or incidental proximal lower extremity DVT [Срок оценки: Approximately 6 months]
  • Time-to-first event of incidental PE (in a segmental or larger pulmonary artery) [Срок оценки: Approximately 6 months]
  • Time-to-first event of asymptomatic VTE (Asymptomatic DVT detected by upper extremity ultrasound) [Срок оценки: Approximately 6 months]
  • Occurrence of Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Up to approximately 9 months]
  • Severity of TEAEs [Срок оценки: Up to approximately 9 months]
  • Concentrations of REGN7508 [Срок оценки: Up to approximately 9 months]
  • Concentrations of REGN9933 [Срок оценки: Up to approximately 9 months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07697599 · R7508-DVT-25103 · 2026-525288-42-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗