Phase 2
Completed N=308
A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery
VTE Prophylaxis With Anticoagulation After Total Knee Replacement Surgery
Source: ClinicalTrials.gov NCT03251482 ↗
Enrolled (actual)
308
Serious AEs
8.5%
Results posted
Nov 2019
Primary outcomePrimary: Number of Participants With Treatment-emergent Bleeding Events (Clinical Events Committee [CEC]- Adjudicated) — 2; 0; 5; 1 Participants
Summary
The primary purpose of Part 1 in this study is to assess the safety and tolerability of JNJ-64179375 for each dose level for dose escalation and any bleeding events (the composite of major, clinically relevant non-major, and minimal bleeding events) for the selection of doses for Part 2. The primary purpose of Part 2 is to assess the efficacy dose response of JNJ-64179375 for the prevention of total venous thromboembolism (VTE) (proximal and/or distal deep vein thrombosis [DVT] [asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic], nonfatal pulmonary embolism [PE], or any death).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Bleeding Events (Clinical Events Committee [CEC]- Adjudicated) |
2; 0; 5; 1; 4 | — |
| PRIMARY Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated) |
10; 9; 9; 31; 6 | — |
| SECONDARY Number of Participants With Composite of Major and CRNM Bleeding Events (CEC-adjudicated) |
1; 0; 2; 1; 0 | — |
| SECONDARY Number of Participants With Major Bleeding Event (CEC-adjudicated) |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Relevant Non-major (CRNM) Bleeding Events (CEC-adjudicated) |
1; 0; 2; 1; 0 | — |
| SECONDARY Number of Participants With Major Bleeding or CRNM Bleeding Events (CEC-adjudicated) |
1; 0; 2; 1; 0 | — |
| SECONDARY Number of Participants With Minimal Bleeding Events (CEC-adjudicated) |
2; 0; 4; 0; 4 | — |
| SECONDARY Number of Participants With Major VTE (CEC-adjudicated) |
2; 2; 1; 7; 0 | — |
| SECONDARY Number of Participants With Proximal Deep Vein Thrombosis (DVT) (CEC-adjudicated) |
1; 2; 0; 3; 0; 0 | — |
| SECONDARY Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated) |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Death (CEC-adjudicated) |
0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Proximal and Distal DVT (CEC-adjudicated) |
1; 0; 1; 4; 0; 0 | — |
| SECONDARY Number of Participants With Distal DVT (CEC-adjudicated) |
8; 7; 8; 24; 6; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Weight greater than or equal to (>=) 40 kg to less than or equal to (<=) 150 kilogram (kg)
- Medically appropriate for postoperative anticoagulant prophylaxis as determined by the investigator
- Has undergone an elective primary unilateral total knee replacement (TKR)
- Before randomization, a woman must not be of childbearing potential defined as postmenopausal (defined as no menses for 12 months without an alternative medical cause) and/ or permanently sterile (include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy)
- Contraceptive use by men should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
Exclusion Criteria
- Any condition for which the use of apixaban is not recommended in the opinion of the investigator
- Bilateral, revision or unicompartmental procedure
- Known or suspected hypersensitivity or intolerance to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies or antibody fragments, or any of the excipients of JNJ-64179375
- Unable to undergo venography
- Known previous deep vein thrombosis (DVT) in either lower extremity
Data sourced from ClinicalTrials.gov (NCT03251482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.