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

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.

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Key information

Conditions

Congenital Bleeding Disorder Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Blood Platelet Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Glanzmann's Disease Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Thrombasthenia

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: activated recombinant factor VII, NovoSeven®

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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multicentre, Non-interventional, Observational Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Jun 13, 2013
Registry last updated: Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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