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NCT02270918 · ClinicalTrials.gov registry record · Phase 1

Reversibility of Apixaban Anticoagulation With the Four Factor Prothrombin Complex Concentrate Kcentra

A Phase 1 study of Thrombosis, sponsored by Thomas Jefferson University.

Completed
Registry status
Phase 1
Development phase
12
Enrollment target
1
Study location

NCT02270918 is a Phase 1 study of Thrombosis that has completed, run by Thomas Jefferson University. The registered enrollment target is 12 participants, below the 470-participant average among 28 other Thrombosis trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02270918, a Phase 1 study of Thrombosis, has completed, sponsored by Thomas Jefferson University.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target
1
Study location

Study Summary

Apixaban is an anticoagulant (also known as blood thinner) approved by the Food and Drug Administration (FDA) for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. It has no reliable method of reversal. Kcentra is an FDA approved drug derived from blood that is used as an antidote to treat people with bleeding associated with taking the well-known anticoagulant warfarin. This is a Phase I, placebo-controlled, single site, open-label, crossover trial to evaluate the reversibility apixaban anticoagulation with Kcentra.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Apixaban
  • DRUG Kcentra

Study Locations (1)

Pennsylvania

  • Thomas Jefferson University Hosptial - Philadelphia

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2014-11
Est. Completion 2014-12
Phase Phase 1

Sponsor

Thomas Jefferson University

292 total trials

What the Registry Record Tells You About NCT02270918

The ClinicalTrials.gov registry entry for NCT02270918 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 470-participant average among 28 other Thrombosis trials with a reported enrollment target (97% lower). The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Thrombosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT02270918 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT02270918 about?

NCT02270918 is a clinical study titled "Reversibility of Apixaban Anticoagulation With the Four Factor Prothrombin Complex Concentrate Kcentra". Apixaban is an anticoagulant (also known as blood thinner) approved by the Food and Drug Administration (FDA) for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. It has no reliable method of reversal. Kcentra is an FDA approved drug derived from b...

What is the current status of trial NCT02270918?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2014-11. Estimated completion is 2014-12.

What conditions does trial NCT02270918 study?

This clinical trial studies the following conditions: Thrombosis.

What interventions are being tested in trial NCT02270918?

The interventions under investigation include: Placebo (DRUG), Apixaban (DRUG), Kcentra (DRUG).

Who is sponsoring clinical trial NCT02270918?

This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02270918 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.