A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC)
- Conditions
- Venous Thromboembolism
- Interventions
- Registration Number
- NCT06299111
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief Summary
This study is researching 2 different experimental drugs called REGN9933 and REGN7508 (called "study drugs"). The study is focused on adults undergoing a placement of a catheter in your vein, also called a 'PICC line'.
The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related disease after catheter placement.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug
* How much study drug is in your blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 195
- PICC 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 ≥50 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
Key
- 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
- History of known thromboembolic disease or thrombophilia
- Participants requiring therapeutic or prophylactic 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 (eg. Hemophilia A or B, von Willebrand's disease)
Note: Other protocol defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description REGN9933 REGN9933 Randomized 1:1:1 REGN7508 REGN7508 Randomized 1:1:1 Placebo Placebo Randomized 1:1:1
- Primary Outcome Measures
Name Time Method Incidence of confirmed VTE per central reading center (CRC) review Through Day 14 Incidence of treatment-emergent adverse event (TEAEs) Up to Day 100 Severity of TEAEs Up to Day 100
- Secondary Outcome Measures
Name Time Method Incidence of confirmed PICC associated venous thrombosis per CRC review Through Day 14 Incidence of major bleeding Through Day 14 Incidence of clinically relevant non-major (CRNM) bleeding Through Day 14 Concentrations of REGN9933 in serum Up to Day 75 Concentrations of REGN7508 in serum Up to Day 75 Change in activated partial thromboplastin time (aPTT) Up to Day 75 Change in prothrombin time (PT) Up to Day 75 Incidence of anti-drug antibody (ADA) to REGN9933 over time Up to Day 75 Titer of ADA to REGN9933 over time Up to Day 75 Incidence of ADA to REGN7508 over time Up to Day 75 Titer of ADA to REGN7508 over time Up to Day 75
Trial Locations
- Locations (12)
Lanadio Medical Center
🇮🇱Netanya, Israel
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Sveta Sofia Hospital
🇧🇬Sofia, Bulgaria
Lakeridge Health
🇨🇦Oshawa, Ontario, Canada
Memorial Sloan Kettering
🇺🇸New York, New York, United States
Soroka University Medical Center
🇮🇱Beer-Sheba, HaDarom, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Yerushalayim, Israel
Hadassah University Medical Center
🇮🇱Jerusalem, Israel
Rabin Medical Center
🇮🇱Petah Tikva, Israel
Sheba Medical Center
🇮🇱Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Arensia Exploratory Medicine Clinic at Country Hospital Cluj-Napoca
🇷🇴Cluj-Napoca, Romania