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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501470-18-00 | Other Identifier | EU CT |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REGN9933 | Experimental | REGN9933 will be administered by intravenous (IV) infusion |
|
| Enoxaparin | Active Comparator | Enoxaparin will be administered by subcutaneous (SC) administration |
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| Apixaban | Active Comparator | Apixaban will be administered orally twice a day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN9933 | Drug | Participants will receive a single dose of REGN9933 by IV infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Confirmed, Adjudicated Venous Thromboembolism (VTE) (REGN9933 vs Enoxaparin) | 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 | Through Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding | International Society on Thrombosis and Hemostasis (ISTH) criteria for Major Bleeding and CRNM Bleeding as described in the protocol | Through Day 12 |
| Percentage of Participants With at Least One Treatment Emergent Adverse Event (TEAE) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg- Campus Sint-Jan | Genk | Limburg | 3600 | Belgium | ||
| MBAL Heart and Brain Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41218619 | Derived | Weitz JI, Kithcart AP, O'Brien MP, Levy O, Marin E, Onisko M, Mohammadi KA, Li D, Meagher KA, Chang HH, Olenchock BA, Gutstein DE, Segers A, Roberts RS, Bonaca MP, Raskob GE. Efficacy and safety of REGN9933A2 and REGN7508Cat for preventing postoperative venous thromboembolism (ROXI-VTE-I and ROXI-VTE-II): two randomised, open-label, phase 2 trials. Lancet. 2025 Nov 29;406(10519):2551-2563. doi: 10.1016/S0140-6736(25)02097-5. Epub 2025 Nov 8. |
| Label | URL |
|---|---|
| Related Info | View source |
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All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
A total of 450 participants were screened for study eligibility, and 77 participants discontinued during the screening period. 373 participants met eligibility criteria and were randomized into 1 of 3 treatment groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | REGN9933 | REGN9933 was administered by intravenous (IV) infusion |
| FG001 | Enoxaparin | Enoxaparin was administered by subcutaneous (SC) administration |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 15, 2023 | May 16, 2025 |
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| Enoxaparin |
| Drug |
Participants will receive enoxaparin by SC administration daily through the time of venography (or day 12, whichever is earlier) |
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| Apixiban | Drug | Participants will receive apixaban orally twice a day through the time of venography (or day 12, whichever is earlier) |
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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. |
| Up to Day 75 |
| Percentage of Participants With Major VTE (REGN9933 vs Enoxaparin) | 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 | Through Day 12 |
| Percentage of Participants With DVT (REGN9933 vs Enoxaparin) | DVT measured by venography of the operated leg | Through Day 12 |
| Total REGN9933 Concentrations in Serum | The concentrations of REGN9933 over time were summarized by descriptive statistics by study arm for the overall population | Days 0.0625 (post-dose), 4, 9, 29, and 74 |
| Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) | 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. | Days 1, 5, 10, 30, and 75 |
| Fold Change From Baseline in Prothrombin Time (PT) | 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. | Days 1, 5, 10, 30, and 75 |
| Number of Participants With Anti-REGN9933 Antibodies by Status | Immunogenicity characterized by anti-drug antibody (ADA) status | Through Day 75 |
| Number of Participants With Treatment-Emergent or Treatment-Boosted Anti-REGN13335 Antibodies by Maximum Titer Level | Immunogenicity characterized per drug molecule by ADA status | Through Day 75 |
| Percentage of Participants With Confirmed, Adjudicated VTE (Enoxaparin vs Apixaban) | 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. | Through Day 12 |
| Pleven |
| 5800 |
| Bulgaria |
| Durham Bone and Joint Specialists | Ajax | Ontario | L1S 7K7 | Canada |
| MAV Korhaz es Rendelointezet Szolnok | Szolnok | Jász-Nagykun-Szolnok | 5000 | Hungary |
| Department of Orthopedics, Somogy County Mór Kaposi Teaching Hospital | Kaposvár | 7400 | Hungary |
| Liepaja Regional Hospital | Liepāja | LV3414 | Latvia |
| Vidzemes Hospital | Riga | LV-1002 | Latvia |
| Riga's 2nd Hospital | Riga | LV-1004 | Latvia |
| Hospital of Traumatology and Orthopaedics | Riga | LV1005 | Latvia |
| Lietuvos Sveikatos Mokslu Universiteto Ligonine Kauno Klinik | Kaunas | Kaunas County | LT-50009 | Lithuania |
| Klaipeda University Hospital | Klaipėda | Klaipėda County | LT-92288 | Lithuania |
| Lietuvos Sveikatos Mokslu Universiteto Kauno Ligoninė | Kaunas | LT-44320 | Lithuania |
| Specjalistyczny Szpital im. E. Szczeklika w Tarnowie | Tarnów | Lesser Poland Voivodeship | 33-100 | Poland |
| SP ZOZ Centralny Szpital Kliniczny UM w Lodzi | Lodz | 90-153 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie | Lublin | 20-954 | Poland |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Radzyniu Podlaskim | Radzyń Podlaski | 21-300 | Poland |
| A Plain Language Summary is available on TrialSummaries.com | View source |
| FG002 | Apixaban | Apixaban was administered orally twice a day |
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| COMPLETED | Randomized participants who completed the study |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | REGN9933 | REGN9933 was administered by intravenous (IV) infusion |
| BG001 | Enoxaparin | Enoxaparin was administered by subcutaneous (SC) administration |
| BG002 | Apixaban | Apixaban was administered orally twice a day |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Confirmed, Adjudicated Venous Thromboembolism (VTE) (REGN9933 vs Enoxaparin) | 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 | Randomized participants in the REGN9933 and enoxaparin arms that had either an evaluable venogram, a confirmed episode of venous thromboembolism, or both. | Posted | Number | percentage of participants | Through Day 12 |
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| Secondary | Number of Participants With Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding | International Society on Thrombosis and Hemostasis (ISTH) criteria for Major Bleeding and CRNM Bleeding as described in the protocol | Randomized participants that had either an evaluable venogram, a confirmed episode of venous thromboembolism, or both. | Posted | Count of Participants | Participants | Through Day 12 |
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| Secondary | Percentage of Participants With at Least One Treatment Emergent Adverse Event (TEAE) | 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. | Posted | Number | percentage of participants | Up to Day 75 |
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| Secondary | Percentage of Participants With Major VTE (REGN9933 vs Enoxaparin) | 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 | Randomized participants in the REGN9933 and enoxaparin arms that had either an evaluable venogram, a confirmed episode of venous thromboembolism, or both. | Posted | Number | percentage of participants | Through Day 12 |
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| Secondary | Percentage of Participants With DVT (REGN9933 vs Enoxaparin) | DVT measured by venography of the operated leg | Randomized participants in the REGN9933 and enoxaparin arms that had either an evaluable venogram, a confirmed episode of venous thromboembolism, or both. | Posted | Number | percentage of participants | Through Day 12 |
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| Secondary | Total REGN9933 Concentrations in Serum | The concentrations of REGN9933 over time were summarized by descriptive statistics by study arm for the overall population | All participants in the REGN9933 treatment group who received study drug and who had at least 1 non-missing result following the first dose of study drug and who were evaluable at time points specified for this outcome measure. | Posted | Mean | Standard Deviation | milligrams/Liter (mg/L) | Days 0.0625 (post-dose), 4, 9, 29, and 74 |
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| Secondary | Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) | 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. | All randomized participants who received any study drug and who had at least 1 non-missing pharmacodynamic (PD) result following the first dose of study drug and who were evaluable at time points specified for this outcome measure. | Posted | Mean | Standard Deviation | Fold Change | Days 1, 5, 10, 30, and 75 |
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| Secondary | Fold Change From Baseline in Prothrombin Time (PT) | 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. | All randomized participants who received any study drug and who had at least 1 non-missing pharmacodynamic (PD) result following the first dose of study drug and who were evaluable at time points specified for this outcome measure. | Posted | Mean | Standard Deviation | Fold Change | Days 1, 5, 10, 30, and 75 |
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| Secondary | Number of Participants With Anti-REGN9933 Antibodies by Status | Immunogenicity characterized by anti-drug antibody (ADA) status | All participants who received study drug REGN9933 and had at least 1 non-missing ADA result following the first dose of study drug | Posted | Count of Participants | Participants | Through Day 75 |
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| Secondary | Number of Participants With Treatment-Emergent or Treatment-Boosted Anti-REGN13335 Antibodies by Maximum Titer Level | Immunogenicity characterized per drug molecule by ADA status | All participants who received study drug REGN9933 and had at least 1 non-missing ADA result following the first dose of study drug | Posted | Count of Participants | Participants | Through Day 75 |
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| Secondary | Percentage of Participants With Confirmed, Adjudicated VTE (Enoxaparin vs Apixaban) | 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. | Randomized participants in the enoxaparin and apixaban arms that had either an evaluable venogram, a confirmed episode of venous thromboembolism, or both. | Posted | Number | percentage of participants | Through Day 12 |
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From date of signing informed consent form (ICF) up to end of study (approximately 105 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | REGN9933 | REGN9933 was administered by intravenous (IV) infusion | 0 | 123 | 4 | 123 | 9 | 123 |
| EG001 | Enoxaparin | Enoxaparin was administered by subcutaneous (SC) administration | 0 | 125 | 1 | 125 | 11 | 125 |
| EG002 | Apixaban | Apixaban was administered orally twice a day | 0 | 125 | 2 | 125 | 16 | 125 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA (27.0) | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Soft tissue infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
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The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Regeneron Pharmaceuticals, Inc. | 844-734-6643 | clinicaltrials@regeneron.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 7, 2023 | May 16, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013927 | Thrombosis |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| C522181 | apixaban |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Negative |
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| Pre-existing Immunoreactivity |
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| Treatment-emergent (TE) Response |
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| Treatment-boosted (TB) Response |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Low (<1,000) |
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| Moderate (1,000 to 10,000) |
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| High (>10,000) |
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