An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency
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
1 other identifier
observational
22
2 countries
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2015
Typical duration for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2015
CompletedFirst Posted
Study publicly available on registry
April 27, 2015
CompletedStudy Start
First participant enrolled
May 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2017
CompletedJanuary 17, 2018
January 1, 2018
2.6 years
April 22, 2015
January 12, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of participants achieving hemostatic efficacy - retrospective
The investigator's overall assessment of hemostatic efficacy of FCH from a review of the subject's historical records.
From the subject's first use of FCH, up to approximately 20 years.
Secondary Outcomes (2)
Percentage of participants achieving hemostatic efficacy - prospective
Approximately 12 months
Percentage of participants with adverse events
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.
Study Arms (1)
Fibrinogen Concentrate, Human (FCH)
A cohort of subjects who have retrospectively received FCH for the treatment of bleeding, routine prophylaxis and/or use in surgery, and who may continue to prospectively receive FCH at the discretion of the treating physician.
Interventions
FCH is a heat-treated, lyophilized fibrinogen (coagulation factor I) powder made from pooled human plasma. FCH is administered as an IV infusion.
Eligibility Criteria
A cohort of subjects who have retrospectively received FCH for the treatment of bleeding, routine prophylaxis and/or use in surgery, and who may continue to prospectively receive FCH at the discretion of the treating physician.
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CSL Behringlead
Study Sites (11)
Study Site
Aurora, Colorado, 80045, United States
Study Site
Las Vegas, Nevada, 89109, United States
Study Site
Durham, North Carolina, 27705, United States
Study Site
Calgary, Alberta, T2N 2T9, Canada
Study Site
Edmonton, Alberta, T6G 2H7, Canada
Study Site
Winnipeg, Manitoba, R3E 0V9, Canada
Study Site
Halifax, Nova Scotia, B3H2Y9, Canada
Study Site
Hamilton, Ontario, L8S 3Z5, Canada
Study Site
Toronto, Ontario, M5B 1W8, Canada
Study Site
Toronto, Ontario, M5G 1X8, Canada
Study Site
Montreal, Quebec, H3T 1C5, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Program Director
CSL Behring
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2015
First Posted
April 27, 2015
Study Start
May 7, 2015
Primary Completion
December 6, 2017
Study Completion
December 6, 2017
Last Updated
January 17, 2018
Record last verified: 2018-01