Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC) (ROXI-PEAK)
6 juli 2026 bijgewerkt door: 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
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
1908
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Clinical Trials Administrator
- Telefoonnummer: 844-734-6643
- E-mail: clinicaltrials@regeneron.com
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Placebo-vergelijker: Placebo
|
Toegediend volgens het protocol
|
|
Experimenteel: REGN7508
|
Toegediend volgens het protocol
Andere namen:
|
|
Experimenteel: Regn9933
|
Toegediend volgens het protocol
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Time-to-first event of centrally adjudicated VTE [symptomatic VTE or incidental VTE or asymptomatic VTE]
Tijdsspanne: 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
Tijdsspanne: Approximately 6 months
|
Approximately 6 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
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]
Tijdsspanne: Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of symptomatic DVT
Tijdsspanne: Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of symptomatic non-fatal PE
Tijdsspanne: Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of VTE-related death
Tijdsspanne: Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of incidental VTE
Tijdsspanne: Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of incidental upper extremity or incidental proximal lower extremity DVT
Tijdsspanne: Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of incidental PE (in a segmental or larger pulmonary artery)
Tijdsspanne: Approximately 6 months
|
Approximately 6 months
|
|
Time-to-first event of asymptomatic VTE (Asymptomatic DVT detected by upper extremity ultrasound)
Tijdsspanne: Approximately 6 months
|
Approximately 6 months
|
|
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Tijdsspanne: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Severity of TEAEs
Tijdsspanne: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Concentrations of REGN7508
Tijdsspanne: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Concentrations of REGN9933
Tijdsspanne: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Change from baseline in activated Partial Thromboplastin Time (aPTT)
Tijdsspanne: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Change from baseline in Prothrombin Time (PT)
Tijdsspanne: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Occurrence of Anti-Drug Antibody (ADA) to REGN7508
Tijdsspanne: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Magnitude of ADA to REGN7508
Tijdsspanne: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Occurrence of ADA to REGN9933
Tijdsspanne: Up to approximately 9 months
|
Up to approximately 9 months
|
|
Magnitude of ADA to REGN9933
Tijdsspanne: Up to approximately 9 months
|
Up to approximately 9 months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Clinical Trial Management, Regeneron Pharmaceuticals
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
20 augustus 2026
Primaire voltooiing (Geschat)
25 juni 2029
Studie voltooiing (Geschat)
21 september 2029
Studieregistratiedata
Eerst ingediend
6 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
6 juli 2026
Eerst geplaatst (Werkelijk)
13 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
13 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
6 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- R7508-DVT-25103
- 2026-525288-42-00 (Ctis)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
IPD-tijdsbestek voor delen
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
IPD-toegangscriteria voor delen
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
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
- ANALYTIC_CODE
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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