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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Congenital Fibrinogen Deficiency
- Sponsor
- CSL Behring
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Percentage of participants achieving hemostatic efficacy - retrospective
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
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
- Not provided
Outcomes
Primary Outcomes
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
- 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.)
- Percentage of participants achieving hemostatic efficacy - prospective(Approximately 12 months)