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โ† Trials
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Venous Thromboembolism (VTE) Prophylaxis With REGN7508 and REGN9933 in Adult and Adolescent Participants With a Peripherally Inserted Central Catheter (PICC)

RecruitingPhase 3Ages 15 Years - anyAllRegeneron Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

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 ma

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค3 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/ Exclusion Criteria Apply
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What it tests

  • REGN7508
  • REGN9933
  • Placebo
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Where

1 site
Arensia Exploratory Medicine at the Research Institute of Clinical Medicine
Tbilisi, Georgia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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