Status:
COMPLETED
Use of rFXIII in Treatment of Congenital FXIII Deficiency, a Prospective Multi-centre Observational Study
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Congenital Bleeding Disorder
Congenital FXIII Deficiency
Eligibility:
All Genders
Brief Summary
This study is conducted globally. The aim of this observational study is to investigate the incidence of specific adverse drug reactions associated with the use of recombinant factor XIII (NovoThirtee...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol)
- Able and willing to provide signed informed consent (or patient's legally acceptable representative (LAR) consent, if applicable), as required by local ethics committee, governmental or regulatory authorities
- Congenital FXIII A-subunit deficiency
- Actual or planned exposure to rFXIII
Exclusion
Key Trial Info
Start Date :
May 17 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 26 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01862367
Start Date
May 17 2013
End Date
June 26 2019
Last Update
July 9 2019
Active Locations (17)
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1
Novo Nordisk Investigational Site
Orange, California, United States, 92868
2
Novo Nordisk Investigational Site
Tampa, Florida, United States, 33607
3
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30322
4
Novo Nordisk Investigational Site
Detroit, Michigan, United States, 48201