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

NCT02427217 · View on ClinicalTrials.gov ↗

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

85 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02427217

The ClinicalTrials.gov registry entry for NCT02427217 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 85 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02427217 reports 11 study locations spanning 8 distinct geographic areas — top geographies include Ontario, Alberta, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02427217?

The interventions under investigation include: FCH (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02427217?

This trial is sponsored by CSL Behring, which has 85 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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