A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan
Completed
- Conditions
- Congenital Bleeding DisorderGlanzmann's Disease
- Interventions
- Registration Number
- NCT01876745
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description NovoSeven® (activated recombinant factor VII) eptacog alfa (activated) -
- Primary Outcome Measures
Name Time Method Therapy-related thrombosis From onset of treatment until 6 hours after treatment onset
- Secondary Outcome Measures
Name Time Method Overall efficacy evaluated by the caregiver/patient: effective, partially effective, ineffective or not possible to evaluate Within 24 hours after surgery for surgery/delivery
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇯🇵Tokyo, Japan