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NCT02427217 · ClinicalTrials.gov registry record

An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency

A clinical trial of Congenital Fibrinogen Deficiency, sponsored by CSL Behring.

Completed
Registry status
22
Enrollment target
11
Study locations

NCT02427217 is a study of Congenital Fibrinogen Deficiency that has completed, run by CSL Behring. The registered enrollment target is 22 participants. The trial reports 11 study locations across 8 states.

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The verdict

NCT02427217, a study of Congenital Fibrinogen Deficiency, has completed, sponsored by CSL Behring.

COMPLETED
Registry status
22 participants
Enrollment target
11
Study locations

Study Summary

This is a multicenter, non interventional, retrospective cohort study with a prospective, observational follow-up component to investigate the safety and efficacy of FCH use in subjects with congenital fibrinogen deficiency. Data will be collected on the safety and efficacy of FCH as used for the treatment of acute bleeding episodes, routine prophylaxis and perioperative bleeding in these subjects. All subjects have received FCH and may continue to receive FCH at the discretion of the treating physician / Primary Investigator according to the standard of care at the participating study site.

Interventions

  • BIOLOGICAL FCH

Study Locations (11)

Ontario

  • Study Site - Hamilton
  • Study Site - Toronto
  • Study Site - Toronto

Alberta

  • Study Site - Calgary
  • Study Site - Edmonton

Colorado

  • Study Site - Aurora

Nevada

  • Study Site - Las Vegas

North Carolina

  • Study Site - Durham

Manitoba

  • Study Site - Winnipeg

Nova Scotia

  • Study Site - Halifax

Quebec

  • Study Site - Montreal

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2015-05-07
Est. Completion 2017-12-06

Sponsor

CSL Behring

71 total trials

What the Registry Record Tells You About NCT02427217

The ClinicalTrials.gov registry entry for NCT02427217 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CSL Behring, which has 71 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Congenital Fibrinogen Deficiency appearing as the primary indexed condition, and to 1 intervention - of which FCH is the first listed.

NCT02427217 reports 11 study locations spanning 8 distinct geographic areas - top geographies include Ontario, Alberta, Colorado.

Frequently Asked Questions

What is clinical trial NCT02427217 about?

NCT02427217 is a clinical study titled "An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency". This is a multicenter, non interventional, retrospective cohort study with a prospective, observational follow-up component to investigate the safety and efficacy of FCH use in subjects with congenital fibrinogen deficiency. Data will be collected on the safety and efficacy of FCH as used for the tr...

What is the current status of trial NCT02427217?

This trial is currently completed. The enrollment target is 22 participants. The study started on 2015-05-07. Estimated completion is 2017-12-06.

What conditions does trial NCT02427217 study?

This clinical trial studies the following conditions: Congenital Fibrinogen Deficiency.

What interventions are being tested in trial NCT02427217?

The interventions under investigation include: FCH (BIOLOGICAL).

Who is sponsoring clinical trial NCT02427217?

This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02427217 being conducted?

This trial has 11 study locations across Colorado, Nevada, North Carolina, Alberta, Manitoba. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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.