REGN7508
DrugAdministered per the protocol
Other names: cenvacibart
NCT Number: NCT07697599
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
Trial opening soon.
Get Notified15 year and older
All sexes
Interventional
Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply
Administered per the protocol
Other names: cenvacibart
Administered per the protocol
Other names: amrecibart
Administered per the protocol
Time frame: Approximately 6 months
Time frame: Approximately 6 months
Time frame: Approximately 6 months
Time frame: Approximately 6 months
Time frame: Approximately 6 months
Time frame: Approximately 6 months
Time frame: Approximately 6 months
Time frame: Approximately 6 months
Time frame: Approximately 6 months
Time frame: Approximately 6 months
Time frame: Up to approximately 9 months
Time frame: Up to approximately 9 months
Time frame: Up to approximately 9 months
Time frame: Up to approximately 9 months
Time frame: Up to approximately 9 months
Time frame: Up to approximately 9 months
Time frame: Up to approximately 9 months
Time frame: Up to approximately 9 months
Time frame: Up to approximately 9 months
Time frame: Up to approximately 9 months
Contact information is provided by the study sponsor or research team.
Regeneron Pharmaceuticals
Industry
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)
Acronym: ROXI-PEAK
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06937372
Cardiovascular Diseases, Embolism and Thrombosis
View Trial DetailsNCT07713875
Bone Diseases, Cardiovascular Diseases
Pittburgh, Pennsylvania, United States
View Trial DetailsNCT07659106
Cardiovascular Diseases, Deep Vein Thrombosis (DVT)
Calgary, Alberta, Canada
View Trial DetailsNCT06628778
Cardiovascular Diseases, Critical Illness
St. Petersburg, Florida, United States
View Trial Details