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OpenTrials
Completed

NCT Number: NCT02427217

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 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.

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Key information

Conditions

Congenital Fibrinogen Deficiency

Sex eligibility

All sexes

Study type

Observational

Primary location

Study Site, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects of any age with a diagnosis of congenital fibrinogen deficiency.
  • Have received FCH (Haemocomplettan® P or RiaSTAP®) for treatment of bleeding, surgery or prophylaxis.

Exclusion criteria

None

Treatment and study plan

FCH

Biological

FCH is a heat-treated, lyophilized fibrinogen (coagulation factor I) powder made from pooled human plasma. FCH is administered as an IV infusion.

Other names: Haemocomplettan® P, RiaSTAP®

Primary outcomes

  1. Percentage of participants achieving hemostatic efficacy - retrospective

    Time frame: From the subject's first use of FCH, up to approximately 20 years.

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

Secondary outcomes

  1. Percentage of participants achieving hemostatic efficacy - prospective

    Time frame: Approximately 12 months

    The investigator's overall assessment of hemostatic efficacy of FCH during the prospective follow-up period.

  2. Percentage of participants with adverse events

    Time frame: Retrospective data collection is from the subject's first use of FCH (up to approximately 20 years); Prospective data collection is from the time of informed consent up to approximately 12 months.

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

A Multicenter Study on the Retrospective Safety and Efficacy of Fibrinogen Concentrate (Human) (FCH) for Routine Prophylaxis, Treatment of Bleeding or Surgery in Subjects With Congenital Fibrinogen Deficiency With a Prospective Followup Component

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 27, 2015
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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