Use of rFXIII in Treatment of Congenital FXIII Deficiency, a Prospective Multi-centre Observational Study



Status:Enrolling by invitation
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:Any
Updated:8/8/2018
Start Date:May 17, 2013
End Date:June 29, 2019

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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 (NovoThirteen®) in patients with congenital FXIII A-subunit deficiency (congenital FXIII
deficiency), comprising FXIII antibodies, allergic reactions, embolic and thrombotic events
and lack of therapeutic effect.

The study will aim at observing all patients exposed to NovoThirteen® in the EU, and
additional patients from selected non-EU countries. Recombinant FXIII (rFXIII) is registered
in EU and Switzerland as NovoThirteen® and in Canada as Tretten®.


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
We found this trial at
8
sites
Detroit, Michigan 48201
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Atlanta, Georgia 30318
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Atlanta, GA
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Cleveland, Ohio 44106
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Cleveland, OH
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Columbus, Ohio 43205
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Columbus, OH
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Minneapolis, Minnesota 55404
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Minneapolis, MN
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Orange, California 92868
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Orange, CA
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St. John's, Newfoundland and Labrador
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St. John's,
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Tampa, Florida 33612
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Tampa, FL
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