Blood-clot prevention with REGN7508 and REGN9933 in people with PICC lines

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 interventional trial evaluating two experimental drugs, REGN7508 and REGN9933, against placebo for venous thromboembolism prevention after PICC placement. Participants include adults and adolescents receiving IV treatments through a PICC. The study will assess efficacy in preventing clots, safety, drug levels over time, anti-drug antibodies, and potential bleeding risks. Investigators will monitor side effects and overall tolerability to determine if the regimens offer a meaningful benefit over placebo.

Why it matters

Who can join: the full rules

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/ Exclusion Criteria Apply

Where it's running

• Arensia Exploratory Medicine at the Research Institute of Clinical Medicine
  Tbilisi, Georgia Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.