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 |
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®.
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
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