Congenital Bleeding Disorder Clinical Trial
Official title:
A Multicentre, Non-interventional, Observational Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan
| Verified date | July 2017 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 4 |
| Est. completion date | June 1, 2017 |
| Est. primary completion date | June 1, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Novo Nordisk Investigational Site | Tokyo |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Therapy-related thrombosis | From onset of treatment until 6 hours after treatment onset | ||
| Secondary | 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 | ||
| Secondary | Overall efficacy evaluated by the caregiver/patient: effective, partially effective, ineffective or not possible to evaluate | Within 24 hours after surgery for surgery/delivery |
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