A 2-Part Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Subjects Undergoing Elective Total Knee Replacement

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004550-15-ES

Enrollment

1500

Registered

2017-07-31

Start date

2017-10-25

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thromboembolism in subjects who have undergone an elective primary unilateral total knee replacement

Interventions

Product Name: JNJ-64179375 Product Code: JNJ-64179375 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Not applicable Cur

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female of non-childbearing potential - At least 50 years of age or older - Weight 40 kg to 150 kg - Medically appropriate for postoperative anticoagulant prophylaxis - Has undergone an elective primary unilateral TKR Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 500

Exclusion criteria

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 DVT in either lower extremity - Any preplanned invasive procedure (eg, surgery, colonoscopy) up to Week 18 for which anticoagulant or antiplatelet therapy would be interrupted - Planned use of intermittent pneumatic compression after randomization

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Through the Day 10-14 visit.; Main Objective: Part 1: The primary objective is to assess the safety and tolerability of JNJ-64179375 for each dose level for dose escalation within Part 1 and any bleeding events (the composite of major, clinically relevant nonmajor, and minimal bleeding events) for the selection of doses for Part 2. Part 2: The primary objective 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 PE, or any death). ; Secondary Objective: Part 1 : • to assess the dose response of JNJ-64179375 for the occurrence of the composite endpoint of any bleeding events, the composite endpoint of major or clinically relevant nonmajor bleeding events, and the individual components of the composite endpoint of any bleeding event • to assess the dose response of JNJ-64179375 for the prevention of total VTE and the individual components of total VTE Part 2: • to assess the dose response of JNJ-64179375 for the occurrence of the composite endpoint of any bleeding events, the composite endpoint of major or clinically relevant nonmajor bleeding events, and the individual components of the composite endpoint of any bleeding event • to assess the dose response of JNJ-64179375 for the prevention of major VTE and the individual components of the total VTE endpoint Please refer to the protocol for further secondary objectives common to both Part 1 and Part 2 ; Primary end point(s): The endpoints of the study will be the same for Parts 1 and 2 although the focus of Part 1 will be primarily dose escalation based on safety w	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Through the Day 10-14 visit.; Main Objective: Part 1: The primary objective is to assess the safety and tolerability of JNJ-64179375 for each dose level for dose escalation within Part 1 and any bleeding events (the composite of major, clinically relevant nonmajor, and minimal bleeding events) for the selection of doses for Part 2. Part 2: The primary objective 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 PE, or any death). ; Secondary Objective: Part 1 : • to assess the dose response of JNJ-64179375 for the occurrence of the composite endpoint of any bleeding events, the composite endpoint of major or clinically relevant nonmajor bleeding events, and the individual components of the composite endpoint of any bleeding event • to assess the dose response of JNJ-64179375 for the prevention of total VTE and the individual components of total VTE Part 2: • to assess the dose response of JNJ-64179375 for the occurrence of the composite endpoint of any bleeding events, the composite endpoint of major or clinically relevant nonmajor bleeding events, and the individual components of the composite endpoint of any bleeding event • to assess the dose response of JNJ-64179375 for the prevention of major VTE and the individual components of the total VTE endpoint Please refer to the protocol for further secondary objectives common to both Part 1 and Part 2 ; Primary end point(s): The endpoints of the study will be the same for Parts 1 and 2 although the focus of Part 1 will be primarily dose escalation based on safety w

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Secondary

Measure	Time frame
Secondary end point(s): Key Secondary Endpoints The key secondary endpoints are the assessment of the primary endpoints through the Week 18 visit, and: • All individual components of the primary safety endpoint (major bleeding, clinically relevant nonmajor bleeding, and minimal bleeding) • Composite of major and clinically relevant nonmajor bleeding • Major VTE, a composite of proximal DVT (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal PE, or any death • All individual components of the primary efficacy endpoint (ie, proximal and/or distal DVT [asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic], nonfatal PE, any death) Other Secondary Endpoints • Any wound or joint complication in the operated leg ;Timepoint(s) of evaluation of this end point: Through the Week 18 visit.	—

Measure

Time frame

Secondary end point(s): Key Secondary Endpoints The key secondary endpoints are the assessment of the primary endpoints through the Week 18 visit, and: • All individual components of the primary safety endpoint (major bleeding, clinically relevant nonmajor bleeding, and minimal bleeding) • Composite of major and clinically relevant nonmajor bleeding • Major VTE, a composite of proximal DVT (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal PE, or any death • All individual components of the primary efficacy endpoint (ie, proximal and/or distal DVT [asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic], nonfatal PE, any death) Other Secondary Endpoints • Any wound or joint complication in the operated leg ;Timepoint(s) of evaluation of this end point: Through the Week 18 visit.

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Countries

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

Contacts

Public ContactGlobal Clinical Operations Spain

Janssen Cilag, S.A.

agonza45@its.jnj.com+34917228100

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026