Venous Thromboembolism
Conditions
Keywords
Anti-factor XI (FXI) monoclonal antibody, Venous Thromboembolism, Peripherally inserted central catheter
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 the 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 the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
Interventions
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. PICC is clinically indicated for at least 14 days and is anticipated to remain in place for at least 14 days 2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 or equivalent functional status as described in the protocol 3. Body weight ≥45 kg and ≤130 kg during the screening period 4. 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 5. Platelet count ≥100 x 10\^9/L during the screening period as described in the protocol Key
Exclusion criteria
1. 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 2. History of prior venous thrombosis in the arm in which the PICC is to be placed 3. Peripheral catheter(s) in the same arm in which the PICC is to be placed or expected need for peripheral catheter(s) placement in the same arm the PICC is to be placed as described in the protocol 4. History of known thromboembolic disease or thrombophilia 5. Participants requiring therapeutic anticoagulation and/or antiplatelet therapy as described in the protocol 6. Expected to receive cancer therapy or other medication associated with a prior episode of Grade 4 thrombocytopenia as described in the protocol 7. Any history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, traumatic spinal or epidural anesthesia, or history of bleeding diathesis (such as but not limited to Hemophilia A or B, von Willebrand's disease, fibrinogen deficiency, and other inherited or acquired bleeding disorders) as described in the protocol Note: Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 confirmed PICC associated venous thrombosis per CRC review | Through Day 14 |
| Magnitude of ADA to REGN9933 over time | Up to Day 75 |
| Incidence of ADA to REGN7508 over time | Up to Day 75 |
| Magnitude of ADA to REGN7508 over time | Up to Day 75 |
| Incidence of anti-drug antibody (ADA) to REGN9933 over time | Up to Day 75 |
| Incidence of major bleeding | Through Day 14 |
| Incidence of clinically relevant non-major (CRNM) bleeding | Through Day 14 |
Countries
Bulgaria, Canada, Israel, Romania, United Kingdom, United States
Outcome results
None listed