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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02427217
Study type Observational
Source CSL Behring
Contact
Status Completed
Phase N/A
Start date May 7, 2015
Completion date December 6, 2017

See also
  Status Clinical Trial Phase
Completed NCT02267226 - Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery Phase 3
Completed NCT01575756 - Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap Phase 2
Recruiting NCT03793426 - Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency
Completed NCT02408484 - Study to Assess the Efficacy, Safety and Pharmacokinetic of Octafibrin in Paediatric Subjects With Fibrinogen Deficiency Phase 3