What side effects are associated with this type of intervention?

Common treatments for Deep Vein Thrombosis (DVT) include direct oral anticoagulants (DOACs) like dabigatran, rivaroxaban, and apixaban, as well as low-molecular-weight heparin (LMWH) such as enoxaparin. The known side effects of these anticoagulants primarily include an increased risk of bleeding, which can range from minor bleeding (such as bruising or nosebleeds) to major bleeding events (such as gastrointestinal bleeding or intracranial hemorrhage). Other potential side effects may include gastrointestinal issues (e.g., nausea, dyspepsia), liver enzyme abnormalities, and, in rare cases, allergic reactions. It is important for patients to discuss these risks with their healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

Several FDA-approved anticoagulants are used for the treatment of Deep Vein Thrombosis (DVT), targeting intrinsic and extrinsic coagulation pathways. Notable examples include direct oral anticoagulants (DOACs) such as rivaroxaban, apixaban, and edoxaban, which inhibit factor Xa, and dabigatran, a direct thrombin inhibitor. These medications offer advantages like rapid onset, ease of administration, and predictable pharmacokinetics, making them effective alternatives to traditional therapies like warfarin and low-molecular-weight heparins (e.g., enoxaparin). These treatments align with the mechanisms being studied in the trial for REGN9933.

What other types of research exist?

Promising novel alternatives to REGN9933 for DVT patients in 2024 include direct oral anticoagulants (DOACs) such as apixaban, rivaroxaban, and edoxaban. Additionally, investigational agents like concizumab (an anti-TFPI antibody) and fitusiran (an siRNA therapeutic targeting antithrombin) are also potential options.

← Back to Search

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

Must not have

History of thromboembolic disease or thrombophilia

History of bleeding in the past 6 months requiring hospitalization or transfusion; history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, and traumatic spinal or epidural anesthesia; history of bleeding diathesis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through end of study; approximately day 75

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of blood clots or clotting disorders.

Select...

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

Select...

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

Select...

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of confirmed, adjudicated venous thromboembolism (VTE)

Secondary study objectives

Body Weight Changes

Change in prothrombin time (PT)

Concentrations of REGN9933 in serum

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2023

Completed Phase 2

~430

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Deep Vein Thrombosis (DVT) include anticoagulants like enoxaparin and direct oral anticoagulants (DOACs) such as apixaban. These medications work by inhibiting specific factors in the coagulation cascade—enoxaparin inhibits factor Xa and IIa (thrombin), while apixaban specifically inhibits factor Xa. This inhibition prevents the formation of fibrin, a key component of blood clots, thereby reducing the risk of clot formation and propagation. For DVT patients, understanding these mechanisms is crucial as it helps in selecting the appropriate therapy to prevent complications such as pulmonary embolism and post-thrombotic syndrome, ensuring effective and safe management of the condition.

Current Trends in the Duration of Anticoagulant Therapy for Venous Thromboembolism: A Systematic Review.The mechanisms of cancer-associated thrombosis.