A Trial to Learn How Well REGN9933 Works for Preventing Blood Clots After Knee Replacement Surgery in Adult Participants
NCT ID: NCT05618808
Last Updated: 2025-08-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
373 participants
INTERVENTIONAL
2023-05-24
2024-05-27
Brief Summary
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The secondary objectives of the study are:
* To evaluate the bleeding risk (ie, major and clinically relevant non-major \[CRNM\] bleeding) of REGN9933 after unilateral TKA through time of venography, compared to enoxaparin
* To assess overall safety and tolerability of REGN9933 in participants undergoing TKA
* To evaluate the efficacy of REGN9933 in prevention of clinically relevant VTE, compared to enoxaparin
* To evaluate the efficacy of REGN9933 in prevention of deep venous thrombosis (DVT) detected by venography, compared to enoxaparin
* To evaluate the pharmacokinetics (PK) of REGN9933 after single intravenous (IV) administration
* To assess pharmacodynamic (PD) effects of REGN9933 on intrinsic and extrinsic coagulation pathways
* To assess immunogenicity following a single dose of REGN9933 over time
* To compare the efficacy of enoxaparin and apixaban in prevention of VTE after unilateral TKA
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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REGN9933
REGN9933 will be administered by intravenous (IV) infusion
REGN9933
Participants will receive a single dose of REGN9933 by IV infusion
Enoxaparin
Enoxaparin will be administered by subcutaneous (SC) administration
Enoxaparin
Participants will receive enoxaparin by SC administration daily through the time of venography (or day 12, whichever is earlier)
Apixaban
Apixaban will be administered orally twice a day
Apixiban
Participants will receive apixaban orally twice a day through the time of venography (or day 12, whichever is earlier)
Interventions
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REGN9933
Participants will receive a single dose of REGN9933 by IV infusion
Enoxaparin
Participants will receive enoxaparin by SC administration daily through the time of venography (or day 12, whichever is earlier)
Apixiban
Participants will receive apixaban orally twice a day through the time of venography (or day 12, whichever is earlier)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
50 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Ziekenhuis Oost-Limburg- Campus Sint-Jan
Genk, Limburg, Belgium
MBAL Heart and Brain Hospital
Pleven, , Bulgaria
Durham Bone and Joint Specialists
Ajax, Ontario, Canada
MAV Korhaz es Rendelointezet Szolnok
Szolnok, Jász-Nagykun-Szolnok, Hungary
Department of Orthopedics, Somogy County Mór Kaposi Teaching Hospital
Kaposvár, , Hungary
Liepaja Regional Hospital
Liepāja, , Latvia
Vidzemes Hospital
Riga, , Latvia
Riga's 2nd Hospital
Riga, , Latvia
Hospital of Traumatology and Orthopaedics
Riga, , Latvia
Lietuvos Sveikatos Mokslu Universiteto Ligonine Kauno Klinik
Kaunas, Kaunas County, Lithuania
Klaipeda University Hospital
Klaipėda, Klaipėda County, Lithuania
Lietuvos Sveikatos Mokslu Universiteto Kauno Ligoninė
Kaunas, , Lithuania
Specjalistyczny Szpital im. E. Szczeklika w Tarnowie
Tarnów, Lesser Poland Voivodeship, Poland
SP ZOZ Centralny Szpital Kliniczny UM w Lodzi
Lodz, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Radzyniu Podlaskim
Radzyń Podlaski, , Poland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
A Plain Language Summary is available on TrialSummaries.com
Other Identifiers
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2022-501470-18-00
Identifier Type: OTHER
Identifier Source: secondary_id
R9933-DVT-2230
Identifier Type: -
Identifier Source: org_study_id
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