Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC) (ROXI-PEAK)
6 de julio de 2026 actualizado por: 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
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
1908
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Clinical Trials Administrator
- Número de teléfono: 844-734-6643
- Correo electrónico: clinicaltrials@regeneron.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Key Inclusion Criteria:
- 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
Key Exclusion Criteria:
- 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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: Placebo
|
Administrado según el protocolo.
|
|
Experimental: REGN7508
|
Administrado por el protocolo
Otros nombres:
|
|
Experimental: RegN9933
|
Administrado por el protocolo
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Time-to-first event of centrally adjudicated VTE [symptomatic VTE or incidental VTE or asymptomatic VTE]
Periodo de tiempo: 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
Periodo de tiempo: Approximately 6 months
|
Approximately 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
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]
Periodo de tiempo: Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of symptomatic DVT
Periodo de tiempo: Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of symptomatic non-fatal PE
Periodo de tiempo: Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of VTE-related death
Periodo de tiempo: Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of incidental VTE
Periodo de tiempo: Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of incidental upper extremity or incidental proximal lower extremity DVT
Periodo de tiempo: Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of incidental PE (in a segmental or larger pulmonary artery)
Periodo de tiempo: Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of asymptomatic VTE (Asymptomatic DVT detected by upper extremity ultrasound)
Periodo de tiempo: Approximately 6 months
|
Approximately 6 months
|
|
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Periodo de tiempo: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Severity of TEAEs
Periodo de tiempo: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Concentrations of REGN7508
Periodo de tiempo: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Concentrations of REGN9933
Periodo de tiempo: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Change from baseline in activated Partial Thromboplastin Time (aPTT)
Periodo de tiempo: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Change from baseline in Prothrombin Time (PT)
Periodo de tiempo: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Occurrence of Anti-Drug Antibody (ADA) to REGN7508
Periodo de tiempo: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Magnitude of ADA to REGN7508
Periodo de tiempo: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Occurrence of ADA to REGN9933
Periodo de tiempo: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Magnitude of ADA to REGN9933
Periodo de tiempo: Up to approximately 9 months
|
Up to approximately 9 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Clinical Trial Management, Regeneron Pharmaceuticals
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
20 de agosto de 2026
Finalización primaria (Estimado)
25 de junio de 2029
Finalización del estudio (Estimado)
21 de septiembre de 2029
Fechas de registro del estudio
Enviado por primera vez
6 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
6 de julio de 2026
Publicado por primera vez (Actual)
13 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
6 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R7508-DVT-25103
- 2026-525288-42-00 (Ctis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Marco de tiempo para compartir IPD
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
Criterios de acceso compartido de IPD
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
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .