Clinical trial
A Multicentre, Non-interventional Post Marketing Study of Safety and Effectiveness of NovoThirteenR (rFXIII) During Treatment of Congenital FXIII Deficiency in Japan
Name
NN1841-4211
Description
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.
Trial arms
Trial start
2016-03-16
Estimated PCD
2024-09-30
Trial end
2024-09-30
Treatment
recombinant factor XIII
No treatment given.Patients will be treated according to routine clinical practice at the discretion of the treating physician.
Arms:
NovoThirteen®
Size
8
Primary endpoint
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
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 8, 'type': 'ESTIMATED'}}
Updated at
2023-11-28
1 organization
1 product
2 indications
Organization
Novo NordiskProduct
Recombinant factor XIIIIndication
Congenital Bleeding DisorderIndication
Congenital Factor XIII Deficiency