Congenital Bleeding Disorder, Glanzmann's Disease
Conditions
Brief summary
This study is conducted in Asia. The aim of the study is to evaluate the safety and efficacy of NovoSeven® (activated recombinant factor VII, eptacog alfa (activated)) during bleeding episodes and for the prevention of bleeding during surgery/delivery in patients with Glanzmann's thrombasthenia (GT)/Glanzmann's disease.
Interventions
DRUGeptacog alfa (activated)
Patients will be treated according to routine clinical practice at the direction of the treating physician. Data will be collected once a year after patient is registered with baseline visit until end of the study.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any study-related activities (Study related activity are any procedure related to recording of data according to the protocol). * All-treated patients in the registration period
Exclusion criteria
* Known or suspected allergy to study product(s) or related products * Septicaemia (especially, septicaemia followed severely infected patients caused by gram-negative bacteria \[The risk of DIC (disseminated intravascular coagulation) caused by endotoxemia could not denied\] * Patients with a history of hypersensitivity to any of the product components
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Therapy-related thrombosis | From onset of treatment until 6 hours after treatment onset |
Secondary
| Measure | Time frame |
|---|---|
| Overall efficacy evaluated by the caregiver/patient: effective, partially effective, ineffective or not possible to evaluate | Within 30 days of end of treatment for bleeding episodes |
Countries
Japan
Outcome results
None listed