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A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan | Clinical Trials | Clareo Health

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

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

NCT01876745•Novo Nordisk A/S

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

ALL

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

Locations (1)

Novo Nordisk Investigational Site

Tokyo, Japan

Key Dates

Start Date

October 7, 2014

Primary Completion Date

June 1, 2017

Completion Date

June 1, 2017

Last Updated

July 11, 2017

Enrollment

ACTUAL participants

Conditions

Congenital Bleeding DisorderGlanzmann's Disease

Interventions

eptacog alfa (activated)

DRUG

Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A

NCT02137850

Congenital Bleeding DisorderHaemophilia A

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COMPLETEDPHASE3

Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B

NCT02141074

Congenital Bleeding DisorderHaemophilia B

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A

Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B

A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B

Study Investigating Novoeight®/NovoEight® (Turoctocog Alfa) in Mexican Haemophilia A Patients

Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A

Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors