A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan

Novo Nordisk

Status: Completed

Conditions: Glanzmann's Disease; Congenital Bleeding Disorder

Treatments: Drug: eptacog alfa (activated)

Study type: Observational

Funder types: Industry

Identifiers

NCT01876745

F7HAEM-4030

U1111-1139-9589 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

4 participants in 1 patient group

NovoSeven® (activated recombinant factor VII)

Treatment:

Drug: eptacog alfa (activated)