Clinical trial NCT02427217: An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Fibrinogen Deficiency
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2015-04-27
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of participants achieving hemostatic efficacy - retrospective
timeFrame: From the subject's first use of FCH, up to approximately 20 years.
Secondary outcomes:
measure: Percentage of participants achieving hemostatic efficacy - prospective
timeFrame: Approximately 12 months
measure: Percentage of participants with adverse events
timeFrame: 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.
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Study Site
state: Colorado
city: Las Vegas
country: United States
facility: Study Site
state: Nevada
city: Durham
country: United States
facility: Study Site
state: North Carolina
city: Calgary
country: Canada
facility: Study Site
state: Alberta
city: Edmonton
country: Canada
facility: Study Site
state: Alberta
city: Winnipeg
country: Canada
facility: Study Site
state: Manitoba
city: Halifax
country: Canada
facility: Study Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: Study Site
state: Ontario
city: Toronto
country: Canada
facility: Study Site
state: Ontario
city: Toronto
country: Canada
facility: Study Site
state: Ontario
city: Montreal
country: Canada
facility: Study Site
state: Quebec
Study officials:
affiliation: CSL Behring
name: Program Director
role: STUDY_DIRECTOR
References: