CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 308 enrolled
Drug / intervention
JNJ-64179375 0.3 mg/kg +10 moredrug
Likely dose
JNJ-64179375 0.3 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03251482
NCT03251482Phase 2Completed
CompareCT.gov

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

Janssen Research & Development, LLC·interventional·Posted Aug 16, 2017·Updated Nov 25, 2019

In Brief

A Phase 2 clinical trial evaluating JNJ-64179375 0.3 mg/kg, JNJ-64179375 0.6 mg/kg, and 9 other interventions for VTE Prophylaxis With Anticoagulation After Total Knee Replacement Surgery. Completed, enrolled 308 participants across 103 sites in 16 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVTE Prophylaxis With Anticoagulation After Total Knee Replacement Surgery
CountriesArgentina, Belgium, Brazil, Bulgaria, Canada, Italy, Japan, Latvia, Lithuania, Malaysia, Poland, Russia, Spain, Turkey (Türkiye), Ukraine, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 16, 2017
Enrollment StartNov 13, 2017
Primary CompletionNov 5, 2018
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 8.9 years ago

Interventions

JNJ-64179375 0.3 mg/kgdrug

JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenous (IV) infusion as a single dose on Day 1.

JNJ-64179375 0.6 mg/kgdrug

JNJ-64179375 0.6 mg/kg IV infusion as a single dose on Day 1.

JNJ-64179375 1.2 mg/kgdrug

JNJ-64179375 1.2 mg/kg IV infusion as a single dose on Day 1.

JNJ-64179375 (Dose to be Determined)drug

JNJ-64179375 IV infusion (Dose to be determined) as a single dose on Day 1.

JNJ-64179375 A mg/kgdrug

JNJ-64179375 Dose A mg/kg IV as a single dose on Day 1.

JNJ-64179375 B mg/kgdrug

JNJ-64179375 Dose B mg/kg IV as a single dose on Day 1.

JNJ-64179375 C mg/kgdrug

JNJ-64179375 Dose C mg/kg IV as a single dose on Day 1.

JNJ-64179375 D mg/kgdrug

JNJ-64179375 Dose D mg/kg IV as a single dose on Day 1.

Placebo JNJ-64179375drug

Matching JNJ-64179375 placebo (normal saline) administered as IV infusion as a single dose on Day 1.

Apixaban placebodrug

Matching apixaban placebo administered orally twice a day for 10 to 14 days.

Apixaban 2.5 mgdrug

Apixaban 2.5 mg administered orally twice a day for 10 to 14 days.