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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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2015-05-07 |
| Est. Completion | 2017-12-06 |
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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