Venous Thromboembolism (VTE)
Conditions
Keywords
Peripherally Inserted Central Catheter (PICC), Blood clots
Brief summary
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
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
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. 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 2. Has Eastern Cooperative Oncology Group Performance (ECOG) Status ≤3 or equivalent functional status as described in the protocol 3. Has International Normalization Ratio (INR) and aPTT values no more than 25% above the upper limit as described in the protocol 4. Weighs at least 40 kg during the screening period Key
Exclusion criteria
1. Has a history of prior venous thrombosis in the arm and/or ipsilateral thoracic central veins in which the PICC is to be placed 2. Has acute leukemia, myelodysplastic syndrome, or primary and secondary myelofibrosis 3. Has unresected luminal gastrointestinal (GI) (including esophageal) or unresected genitourinary (GU) malignancy 4. Has current or history of known brain tumors or brain metastases 5. Has any major cardiovascular event within approximately the past 30 days prior to study administration 6. Pre-existing central venous catheter or indwelling spinal or epidural catheter during the screening period Note: Other Protocol Defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time-to-first event of centrally adjudicated VTE [symptomatic VTE or incidental VTE or asymptomatic VTE] | 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 | Approximately 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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] | Approximately 6 months |
| Time-to-first event of symptomatic DVT | Approximately 6 months |
| Time-to-first event of symptomatic non-fatal PE | Approximately 6 months |
| Time-to-first event of VTE-related death | Approximately 6 months |
| Time-to-first event of incidental VTE | Approximately 6 months |
| Time-to-first event of incidental upper extremity or incidental proximal lower extremity DVT | Approximately 6 months |
| Time-to-first event of incidental PE (in a segmental or larger pulmonary artery) | Approximately 6 months |
| Time-to-first event of asymptomatic VTE (Asymptomatic DVT detected by upper extremity ultrasound) | Approximately 6 months |
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Up to approximately 9 months |
| Severity of TEAEs | Up to approximately 9 months |
| Concentrations of REGN7508 | Up to approximately 9 months |
| Concentrations of REGN9933 | Up to approximately 9 months |
| Change from baseline in activated Partial Thromboplastin Time (aPTT) | Up to approximately 9 months |
| Change from baseline in Prothrombin Time (PT) | Up to approximately 9 months |
| Occurrence of Anti-Drug Antibody (ADA) to REGN7508 | Up to approximately 9 months |
| Magnitude of ADA to REGN7508 | Up to approximately 9 months |
| Occurrence of ADA to REGN9933 | Up to approximately 9 months |
| Magnitude of ADA to REGN9933 | Up to approximately 9 months |
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed