An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02427217|
Recruitment Status : Completed
First Posted : April 27, 2015
Last Update Posted : January 17, 2018
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|Condition or disease||Intervention/treatment|
|Congenital Fibrinogen Deficiency||Biological: FCH|
|Study Type :||Observational|
|Actual Enrollment :||22 participants|
|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|
|Actual Study Start Date :||May 7, 2015|
|Actual Primary Completion Date :||December 6, 2017|
|Actual Study Completion Date :||December 6, 2017|
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.
FCH is a heat-treated, lyophilized fibrinogen (coagulation factor I) powder made from pooled human plasma. FCH is administered as an IV infusion.
- 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.
- 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.
- 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. ]
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427217
|United States, Colorado|
|Aurora, Colorado, United States, 80045|
|United States, Nevada|
|Las Vegas, Nevada, United States, 89109|
|United States, North Carolina|
|Durham, North Carolina, United States, 27705|
|Calgary, Alberta, Canada, T2N 2T9|
|Edmonton, Alberta, Canada, T6G 2H7|
|Winnipeg, Manitoba, Canada, R3E 0V9|
|Canada, Nova Scotia|
|Halifax, Nova Scotia, Canada, B3H2Y9|
|Hamilton, Ontario, Canada, L8S 3Z5|
|Toronto, Ontario, Canada, M5B 1W8|
|Toronto, Ontario, Canada, M5G 1X8|
|Montreal, Quebec, Canada, H3T 1C5|
|Study Director:||Program Director||CSL Behring|
|Responsible Party:||CSL Behring|
|Other Study ID Numbers:||
|First Posted:||April 27, 2015 Key Record Dates|
|Last Update Posted:||January 17, 2018|
|Last Verified:||January 2018|
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Coagulation Protein Disorders
Genetic Diseases, Inborn