REGN9933 for Preventing Blood Clots After Knee Surgery

Recruiting in Palo Alto (17 mi)

+18 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Regeneron Pharmaceuticals

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing REGN9933, a new medication, to see if it can prevent blood clots in patients having knee replacement surgery. The medication works by stopping clots from forming in the blood vessels.

Eligibility Criteria

Adults in good health needing knee replacement surgery can join this trial. They should weigh no more than 130 kg and have stable vital signs, normal ECG, and lab tests. People with recent bleeding issues, thromboembolic disease, major surgeries or trauma within the last 6 months, or severe kidney problems cannot participate.

Inclusion Criteria

My weight is 130 kg or less.

I am scheduled for a knee replacement surgery on one knee.

Exclusion Criteria

I have a history of blood clots or clotting disorders.

I have not had serious bleeding issues or needed a blood transfusion in the last 6 months.

I have not been in the hospital for more than a day in the last month.

I haven't had major surgery in the last 6 months.

Participant Groups

The study is testing REGN9933's effectiveness at preventing blood clots after knee surgery compared to enoxaparin. It will also compare the risk of bleeding between these drugs and assess REGN9933's overall safety and how it affects blood clotting pathways.

3Treatment groups

Experimental Treatment

Active Control

Group I: REGN9933Experimental Treatment1 Intervention

REGN9933 will be administered by intravenous (IV) infusion

Group II: EnoxaparinActive Control1 Intervention

Enoxaparin will be administered by subcutaneous (SC) administration

Group III: ApixabanActive Control1 Intervention

Apixaban will be administered orally twice a day