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

CompletedOBSERVATIONAL
Enrollment

22

Participants

Timeline

Start Date

May 7, 2015

Primary Completion Date

December 6, 2017

Study Completion Date

December 6, 2017

Conditions
Congenital Fibrinogen Deficiency
Interventions
BIOLOGICAL

FCH

FCH is a heat-treated, lyophilized fibrinogen (coagulation factor I) powder made from pooled human plasma. FCH is administered as an IV infusion.

Trial Locations (11)

27705

Study Site, Durham

80045

Study Site, Aurora

89109

Study Site, Las Vegas

T2N 2T9

Study Site, Calgary

T6G 2H7

Study Site, Edmonton

R3E 0V9

Study Site, Winnipeg

B3H2Y9

Study Site, Halifax

L8S 3Z5

Study Site, Hamilton

M5B 1W8

Study Site, Toronto

M5G 1X8

Study Site, Toronto

H3T 1C5

Study Site, Montreal

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CSL Behring

INDUSTRY

NCT02427217 - An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency | Biotech Hunter | Biotech Hunter