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Study of PER977 Administered to Subjects With Steady State Edoxaban Dosing and Re-anticoagulation With Edoxaban

NCT02207257 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2020-05-21

No results posted yet for this study

Summary

This study will evaluate the establishment of anticoagulation ("re-anticoagulation") of subjects with edoxaban following reversal by PER977 and will identify a dose regimen of PER977 that reverses the effects of edoxaban for up to 21 hours.

Conditions

  • Anticoagulation Reversal

Interventions

DRUG

PER977

Reversal of edoxaban-induced anticoagulation

DRUG

Placebo

Reversal of edoxaban-induced anticoagulation

DRUG

Edoxaban

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Scott Rasmussen, MD · Quintiles, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-09-30
Completion
2015-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02207257 on ClinicalTrials.gov