A trial to learn how well REGN9933 works for preventing blood clots after knee replacement surgery in adult participants

Phase 1

• Conditions: Thromboembolic disease; MedDRA version: 21.1Level: LLTClassification code: 10043565Term: Thromboembolic event Class: 10047065; Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2022-501470-18-00
• Lead Sponsor: Regeneron Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-12
• Study Completion: 2024-05-28
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 432

Inclusion Criteria

1. Undergoing elective unilateral TKA, 2. Has a body weight =130 kg at screening visit, 3. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and Electrocardiograms (ECG) performed at screening and/or prior to administration of initial dose of study drug, 4. Is in good health based on laboratory safety testing obtained during the screening period as described in the protocol, Other protocol-defined inclusion criteria apply

Exclusion Criteria

1. 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., 2. History of thromboembolic disease or thrombophilia., 3. History of major surgery, including brain, spinal, or ocular, within approximately the past 6 months., 4. History of major trauma within approximately the past 6 months., 5. Hospitalized (>24 hours) for any reason within 30 days of the screening visit., 6. Using the Modification of Diet in Renal Disease equation, has an estimated glomerular filtration rate as described in the protocol., Other protocol-defined exclusion criteria apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified