At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 108 enrolled
Drug / intervention
Andexanet alfa +4 morebiological
Likely dose
Not stated in 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.
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Andexanet Alfa Administered to Healthy Japanese and Caucasian Subjects
In Brief
A Phase 2 clinical trial evaluating Andexanet alfa, Apixaban, and 3 other interventions for Bleeding. Completed, enrolled 108 participants across 1 site.
Detailed Summary
"This is a single-center, randomized, double-blind, and placebo-controlled trial designed to: 1) demonstrate the degree to which administered andexanet doses can reverse Factor Ten A (FXa)-inhibitor induced anticoagulation; and 2) evaluate the safety and PK/PD of andexanet in healthy Japanese subjects taking direct FXa inhibitors at therapeutic doses."
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBleeding
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
Enrollment StartAug 2017
First PostedOct 2017
Primary CompletionAug 2019
TodayJul 2026
First PostedOct 16, 2017
Enrollment StartAug 28, 2017
Primary CompletionAug 13, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.7 years ago
Interventions
Andexanet alfabiological
fXa inhibitor antidote
Apixabandrug
factor Xa inhibitor
Rivaroxabandrug
factor Xa inhibitor
Edoxabandrug
factor Xa inhibitor
Placebodrug
Placebo