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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie eptacog alfa's efficacy in Glanzmann's thrombasthenia patients with GPIIb/IIIa deficiency?
How does NovoSeven® compare to desmopressin and antifibrinolytic agents in managing bleeding episodes in GT patients?
Are there specific biomarkers that correlate with reduced bleeding risk during surgery in GT patients treated with activated factor VII?
What adverse events are associated with long-term use of eptacog alfa in congenital platelet function disorders and how are they managed?
What alternative or combination therapies are being explored for Glanzmann's disease besides recombinant factor VIIa like NovoSeven®?
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇯🇵Tokyo, Japan
Novo Nordisk Investigational Site🇯🇵Tokyo, Japan