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

Novo Nordisk A/S4 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Congenital Bleeding Disorder Glanzmann's Disease

Interventions

eptacog alfa (activated)DRUG

Patients will be treated according to routine clinical practice at the direction of the treating physician. Data will be collected once a year after patient is registered with baseline visit until end of the study.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Novo Nordisk Investigational Site

Tokyo, Japan

Outcomes

Primary Outcomes

Therapy-related thrombosis

Time frame: From onset of treatment until 6 hours after treatment onset

Secondary Outcomes

Overall efficacy evaluated by the caregiver/patient: effective, partially effective, ineffective or not possible to evaluate

Time frame: Within 30 days of end of treatment for bleeding episodes

Overall efficacy evaluated by the caregiver/patient: effective, partially effective, ineffective or not possible to evaluate

Time frame: Within 24 hours after surgery for surgery/delivery

Data from ClinicalTrials.gov

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