REGN9933 + REGN7508 for Venous Thromboembolism

(ROXI-CATH Trial)

Recruiting at 13 trial locations

Overseen By Clinical Trials Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Regeneron Pharmaceuticals

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Thrombosis, Thrombophilia, Bleeding disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

195 Participants Needed

Trial Summary

What is the purpose of this trial?

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)

Will I have to stop taking my current medications?

The trial requires that participants do not take anticoagulation (blood-thinning) or antiplatelet medications. If you are on these medications, you may need to stop them to join the study.

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

This trial is for adults who are having a PICC line inserted and expect it to stay in place for at least 14 days. They should be relatively active (ECOG ≤2), weigh between 50-130 kg, have normal blood clotting tests (INR and aPTT), and platelet count above 100 x 10^9/L.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

My blood clotting tests are within normal range.

My platelet count is at least 100,000 per microliter.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either REGN9933, REGN7508, or placebo to evaluate effectiveness in preventing venous thromboembolism after PICC line placement

6 weeks

Follow-up

Participants are monitored for safety, effectiveness, and side effects after treatment

4 weeks

Treatment Details

Interventions

• REGN7508
• REGN9933

Trial Overview The study is testing the effectiveness of two experimental drugs, REGN9933 and REGN7508, in preventing blood clots after PICC line placement. It also examines side effects, drug levels in the blood over time, and if the body creates antibodies against these drugs.

Participant Groups

Group I: REGN9933 Experimental Treatment 1 Intervention

Randomized 1:1:1

Group II: REGN7508 Experimental Treatment 1 Intervention

Randomized 1:1:1

Group III: Placebo Placebo Group 1 Intervention

Randomized 1:1:1

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School