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NCT02207257 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
65
Enrollment target

NCT02207257: Completed Phase 2 study, sponsored by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals.

NCT02207257 is a Phase 2 study that has completed, run by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals. The registered enrollment target is 65 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02207257, a Phase 2 study, has completed, sponsored by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
65 participants
Enrollment target

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.

Primary Outcome

To evaluate the safety, tolerability and effect on whole blood clotting time of escalating intravenous doses of PER977 (25, 50, 100, 300 mg, and 600 mg) administered after 60 mg edoxaban as a "rescue" medication in healthy volunteers and repeated for a second day to investigate any effects of PER977 on the re-anticoagulation with edoxaban and second reversal with PER977.

Interventions

  • DRUG Placebo
  • DRUG Edoxaban
  • DRUG PER977

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2014-03
Est. Completion 2015-11
Phase Phase 2
Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals

9 total trials

What the finished NCT02207257 record still lists

NCT02207257 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT02207257 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02207257 about?

NCT02207257 is a clinical study titled "Study of PER977 Administered to Subjects With Steady State Edoxaban Dosing and Re-anticoagulation With Edoxaban". 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.

What is the current status of trial NCT02207257?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2014-03. Estimated completion is 2015-11.

What interventions are being tested in trial NCT02207257?

The interventions under investigation include: Placebo (DRUG), Edoxaban (DRUG), PER977 (DRUG).

Who is sponsoring clinical trial NCT02207257?

This trial is sponsored by Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT02207257's enrollment target sits among peer trials

65 987th of 2000 higher than 1,005 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02207257, the US trial registry maintained by the National Library of Medicine. NCT02207257 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.