Clinical Trial: An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
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 The investigator's overall assessment of hemostatic efficacy of FCH from a review of the subject's historical records.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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. ]
Original Secondary Outcome: Same as current
Information By: CSL Behring
Dates:
Date Received: April 22, 2015
Date Started: May 2015
Date Completion: December 2017
Last Updated: April 21, 2017
Last Verified: April 2017