Status:
COMPLETED
A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Congenital Bleeding Disorder
Glanzmann's Disease
Eligibility:
All Genders
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 7 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01876745
Start Date
October 7 2014
End Date
June 1 2017
Last Update
July 11 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005