clinical trial · NCT04543383
A Study to Assess the Reversal of the Anticoagulant Effects of Milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) (Part 1) and Recombinant Human Factor VIIa (rFVIIa) (Part 2) in Healthy Participants
Janssen Research & Development, LLC·phase1·completed·n = 52
HealthyMilvexian4-Factor Prothrombin Complex Concentrate (4F-PCC)Recombinant Human Factor VIIa (rFVIIa)Placebo matching to 4F-PCCPlacebo matching to rFVIIa
brief summary
The primary purpose of this study is to evaluate the reversal of the anticoagulant effects of milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) and Recombinant Human Factor VIIa (rFVIIa) in healthy participants as measured by changes from baselines of the coagulation testing parameters (activated partial thromboplastin time \[aPTT\] and thrombin generation assay \[TGA\]).
started
Jul 27, 2020
primary completion
Jun 7, 2023
completion
Jun 9, 2023
last updated
Aug 15, 2025
official title
A Two-Part, Open-Label, Randomized, Placebo-Controlled Crossover Study to Assess the Reversal of the Anticoagulant Effects of Milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) (Part 1) and Recombinant Human Factor VIIa (rFVIIa) (Part 2) in Healthy Subjects
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol