Congenital Bleeding Disorder, Congenital FXIII Deficiency
Conditions
Brief summary
This study is conducted in Asia. Tha aim of this study is to investigate Safety and Effectiveness of NovoThirteen® (rFXIII) during treatment of congenital FXIII deficiency in Japan.
Interventions
No treatment given.Patients will be treated according to routine clinical practice at the discretion of the treating physician.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Male of female patients, regardless of age, requiring treatment with NovoThirteenR for whom the treating physician has decided to use NovoThirteenR (rFXIII) treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse drug reactions in patients with congenital FXIII A-subunit deficiency treated with NovoThirteen®, comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of therapeutic effect | Year 0-9 |
Secondary
| Measure | Time frame |
|---|---|
| All adverse events | Year 0-9 |
| All medical event of special interest | Year 0-9 |
| All medication errors collected | Year 0-9 |
| All serious adverse events | Year 0-9 |
| Use of NovoThirteen® for other uses than for the approved indication | Year 0-9 |
| Frequency of bleeding episodes | Year 0-9 |
| All technical complaints | Year 0-9 |
Countries
Japan
Outcome results
None listed