REGN9933
DrugParticipants will receive a single dose of REGN9933 by IV infusion
NCT Number: NCT05618808
The primary objective of the study is to evaluate the efficacy of REGN9933 for the prevention of venous thromboembolism (VTE) after unilateral total knee arthroplasty (TKA), compared to enoxaparin
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
Looking for future studies?
Notify Me50 year and older
All sexes
Interventional
Phase 2
Ziekenhuis Oost-Limburg- Campus Sint-Jan, Genk, Limburg, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Participants will receive a single dose of REGN9933 by IV infusion
Participants will receive enoxaparin by SC administration daily through the time of venography (or day 12, whichever is earlier)
Other names: Lovenox
Participants will receive apixaban orally twice a day through the time of venography (or day 12, whichever is earlier)
Other names: Eliquis
Time frame: Through Day 12
Composite endpoint that includes: asymptomatic deep DVT (deep venous thrombosis) detected by unilateral venography of the operated leg; confirmed symptomatic DVT of either leg; confirmed fatal or nonfatal pulmonary embolism (PE) including unexplained death for which PE cannot be ruled out
Time frame: Through Day 12
International Society on Thrombosis and Hemostasis (ISTH) criteria for Major Bleeding and CRNM Bleeding as described in the protocol
Time frame: Up to Day 75
A TEAE is any untoward medical occurrence in a participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Time frame: Through Day 12
Major VTE is a composite endpoint that includes: proximal DVT; confirmed symptomatic DVT of either leg; confirmed fatal or nonfatal PE including unexplained death for which PE cannot be ruled out
Time frame: Through Day 12
DVT measured by venography of the operated leg
Time frame: Days 0.0625 (post-dose), 4, 9, 29, and 74
The concentrations of REGN9933 over time were summarized by descriptive statistics by study arm for the overall population
Time frame: Days 1, 5, 10, 30, and 75
aPTT was used to measure the anticipated anticoagulant effect of REGN9933. Fold change is based on the follow-up value/baseline value within an arm.
Time frame: Days 1, 5, 10, 30, and 75
PT is a measure of extrinsic and/or common pathway function. Fold change is based on the follow-up value/baseline value within an arm.
Time frame: Through Day 75
Immunogenicity characterized by anti-drug antibody (ADA) status
Time frame: Through Day 75
Immunogenicity characterized per drug molecule by ADA status
Time frame: Through Day 12
Asymptomatic deep DVT detected by unilateral venography of the operated leg; confirmed symptomatic DVT of either leg; confirmed fatal or nonfatal pulmonary embolism (PE) including unexplained death for which PE cannot be ruled out.
Regeneron Pharmaceuticals
Industry
A Phase 2, Multicenter, Randomized, Open-Label, Active-Control Study of REGN9933, a Factor XI Monoclonal Antibody, for Prevention of Venous Thromboembolism After Elective, Unilateral, Total Knee Arthroplasty
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06495996
Cardiovascular Diseases, Deep Venous Thrombosis
Newport Beach, California, United States
View Trial DetailsNCT07689136
Cardiovascular Diseases, Deep Vein Thrombosis
Tunis, Tunisia
View Trial DetailsNCT04349189
Anemia, Anemia, Hemolytic
Bethesda, Maryland, United States
View Trial DetailsNCT04737954
Cardiovascular Diseases, Deep Vein Thrombosis
Hamburg, Germany
View Trial Details