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Monoclonal Antibodies

REGN9933 for Preventing Blood Clots After Knee Surgery

Phase 2

Waitlist Available

Research Sponsored by Regeneron Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has a body weight ≤130 kg at screening visit

Undergoing elective unilateral TKA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through end of study; approximately day 75

Awards & highlights

Study Summary

This trial will compare the safety and effectiveness of a new drug, REGN9933, for preventing venous thromboembolism after knee surgery, to a standard drug, enoxaparin.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects include various types of bleeding risks such as major bleeds or clinically relevant non-major bleeds. The drug might also affect liver enzymes, cause allergic reactions, or influence coagulation markers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My weight is 130 kg or less.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through end of study; approximately day 75

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through end of study; approximately day 75

This trial's timeline: 3 weeks for screening, Varies for treatment, and through end of study; approximately day 75 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of confirmed, adjudicated venous thromboembolism (VTE)

Secondary outcome measures

Body Weight Changes

Change in prothrombin time (PT)

Concentrations of REGN9933 in serum

+8 more

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

REGN9933

2021

Completed Phase 1

~60

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor

621 Previous Clinical Trials

380,232 Total Patients Enrolled

Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals

263 Previous Clinical Trials

251,041 Total Patients Enrolled

Media Library

Deep Vein Thrombosis Clinical Trial 2023: REGN9933 Highlights & Side Effects. Trial Name: NCT05618808 — Phase 2

REGN9933 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05618808 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the approximate number of accepted participants in this medical experiment?

"Yes, according to clinicaltrials.gov's information, this trial is currently recruiting individuals for participation. The study was first made available on May 24th 2023 and has recently been updated on June 20th of the same year. 360 participants are being recruited from a single research site."

Answered by AI

Are there any open enrollment opportunities for this research project?

"Affirmative. Clinicaltrials.gov data reveals that this research endeavour, which was initially posted on May 24th 2023, is in the process of enrolling participants. A total of 360 patients are required for 1 medical centre to be fully recruited."

Answered by AI

To what degree can REGN9933 be detrimental to human health?

"On a scale of 1 to 3, our team gave REGN9933 a score of 2 due to the fact that only limited clinical data exists confirming its safety and none affirming its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial to Learn How Well REGN9933 Works for Preventing Blood Clots After Knee Replacement Surgery in Adult Participants

2023. "A Trial to Learn How Well REGN9933 Works for Preventing Blood Clots After Knee Replacement Surgery in Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05618808.