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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: Completed study of Congenital Fibrinogen Deficiency, sponsored by CSL Behring.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The investigator's overall assessment of hemostatic efficacy of FCH from a review of the subject's historical records.

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
CSL Behring

71 total trials

What the finished NCT02427217 record still lists

NCT02427217 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 22 participants, a relatively small participant target.

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 lists 11 locations in 8 states (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.

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Source: ClinicalTrials.gov NCT02427217, the US trial registry maintained by the National Library of Medicine. NCT02427217 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.