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 Co

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 Summary:
Sponsor: CSL Behring

Current Primary Outcome: 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.


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