REGN9933 + REGN7508 for Venous Thromboembolism
(ROXI-CATH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two experimental drugs, REGN9933 and REGN7508, to determine their effectiveness in preventing blood clots (venous thromboembolism) in individuals with a catheter placed in their vein (PICC line). Researchers aim to assess the efficacy of these drugs, identify potential side effects, and observe any bodily reactions that could reduce their effectiveness. Individuals who have had a catheter inserted for at least two weeks and are not on certain blood-thinning medications may qualify for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that REGN9933 and REGN7508 are under study to determine if they can prevent blood clots without increasing bleeding risk. Earlier studies on REGN9933 found that it affected blood clotting in a controlled manner, suggesting potential safety. Initial trials with healthy volunteers assessed the tolerability of REGN9933, though specific safety details were not provided.
Similarly, REGN7508 has undergone testing to understand its mechanism in the body. These studies evaluated the drug's safety and tolerability without major issues. As this trial is in the middle phase, the drugs have passed initial safety checks, but detailed safety information may still be limited.
Both drugs are being investigated to ensure efficacy without causing serious side effects. Prospective participants should discuss any concerns with the trial team to understand what to expect.12345Why are researchers excited about this trial's treatments?
Researchers are excited about REGN9933 and REGN7508 for treating venous thromboembolism (VTE) because they offer a fresh approach compared to the standard anticoagulants like warfarin and direct oral anticoagulants (DOACs). Unlike these traditional treatments that primarily thin the blood to prevent clotting, REGN9933 and REGN7508 target specific pathways involved in clot formation, potentially improving safety and effectiveness. This targeted mechanism might reduce the risk of bleeding, a common side effect of current therapies. If successful, these treatments could change how we manage VTE by offering more precise control over clot prevention.
What evidence suggests that this trial's treatments could be effective for preventing venous thromboembolism?
In this trial, participants will receive either REGN9933 or REGN7508, both of which have shown promise in previous studies. REGN9933 has proven effective in preventing blood clots, particularly after surgeries like knee replacements, by targeting a part of the blood involved in clotting, aiming to stop clots without causing excessive bleeding. Similarly, REGN7508 was tested against well-known treatments like Eliquis and proved just as effective in preventing dangerous clots in veins, known as venous thromboembolism (VTE). Both drugs have been studied for their ability to control blood clots while maintaining low bleeding risks. These findings suggest that both REGN9933 and REGN7508 could effectively prevent clots after catheter placements.26789
Who Is on the Research Team?
Clinical Trial Management
Principal Investigator
Regeneron Pharmaceuticals
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either REGN9933, REGN7508, or placebo to evaluate effectiveness in preventing venous thromboembolism after PICC line placement
Follow-up
Participants are monitored for safety, effectiveness, and side effects after treatment
What Are the Treatments Tested in This Trial?
Interventions
- REGN7508
- REGN9933
Find a Clinic Near You
Who Is Running the Clinical Trial?
Regeneron Pharmaceuticals
Lead Sponsor
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