A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03251482
• Date of registration: 14/08/2017
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery TEXT-TKR
• Scientific title: A Randomized, Double-blind, Double-dummy, Multicenter, Adaptive Design, Dose Escalation (Part 1) and Dose-Response (Part 2) Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery
• Date of first enrolment: November 13, 2017
• Target sample size: 308
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03251482
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Argentina, Belgium, Brazil, Bulgaria, Canada, Czechia, Greece, Hungary, Italy, Japan, Latvia, Lithuania, Malaysia, Poland, Portugal, Romania, Russian Federation, Spain, Sweden, Thailand, Turkey, Ukraine, United States

Contacts

• Name: Janssen Research Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion 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



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

VTE Prophylaxis With Anticoagulation After Total Knee Replacement Surgery

Intervention(s)

Drug: JNJ-64179375 D mg/kg

Drug: Apixaban placebo

Drug: JNJ-64179375 (Dose to be Determined)

Drug: Apixaban 2.5 mg

Drug: JNJ-64179375 A mg/kg

Drug: JNJ-64179375 1.2 mg/kg

Drug: Placebo JNJ-64179375

Drug: JNJ-64179375 C mg/kg

Drug: JNJ-64179375 0.3 mg/kg

Drug: JNJ-64179375 0.6 mg/kg

Drug: JNJ-64179375 B mg/kg

Primary Outcome(s)

Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated) [Time Frame: Up to Day 10 to 14 (visit observation period)]

Number of Participants With Treatment-emergent Bleeding Events (Clinical Events Committee [CEC]- Adjudicated) [Time Frame: Up to Day 10 to 14 (visit observation period)]

Secondary Outcome(s)

Number of Participants With Composite of Major and CRNM Bleeding Events (CEC-adjudicated) [Time Frame: Up to Day 10 to 14 (visit observation period)]

Number of Participants With Major Bleeding or CRNM Bleeding Events (CEC-adjudicated) [Time Frame: Up to Day 10 and 14 (visit observation period)]

Number of Participants With Clinically Relevant Non-major (CRNM) Bleeding Events (CEC-adjudicated) [Time Frame: Up to Day 10 to 14 (visit observation period)]

Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated) [Time Frame: Up to Day 10 to 14 (visit observation period)]

Number of Participants With Proximal and Distal DVT (CEC-adjudicated) [Time Frame: Up to Day 10 to 14 (visit observation period)]

Number of Participants With Major Bleeding Event (CEC-adjudicated) [Time Frame: Up to Day 10 to 14 (visit observation period)]

Number of Participants With Death (CEC-adjudicated) [Time Frame: Up to Day 10 to 14 (visit observation period)]

Number of Participants With Proximal Deep Vein Thrombosis (DVT) (CEC-adjudicated) [Time Frame: Up to Day 10 to 14 (visit observation period)]

Number of Participants With Major VTE (CEC-adjudicated) [Time Frame: Up to Day 10 to 14 (visit observation period)]

Number of Participants With Distal DVT (CEC-adjudicated) [Time Frame: Up to Day 10 to 14 (visit observation period)]

Number of Participants With Minimal Bleeding Events (CEC-adjudicated) [Time Frame: Up to Day 10 to 14 (visit observation period)]

Secondary ID(s)

CR108344

2016-004550-15

64179375THR2001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 25/11/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03251482