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

Completed

• Conditions: Congenital Fibrinogen Deficiency
• Interventions: Biological: FCH

• Registration Number: NCT02427217
• Lead Sponsor: CSL Behring

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-22
• Study First Submitted QC: 2015-04-22
• Study First Posted: 2015-04-27
• Study Start: 2015-05-07
• Primary Completion: 2017-12-06
• Study Completion: 2017-12-06
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-12
• Last Update Posted: 2018-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

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Exclusion Criteria

None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fibrinogen Concentrate, Human (FCH)	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.

Primary Outcome Measures

Name	Time	Method
Percentage of participants achieving hemostatic efficacy - retrospective	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 Outcome Measures

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

Trial Locations

Locations (1)

Study Site; 🇨🇦 Montreal, Quebec, Canada