Clinical Trial: A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: A Multicentre, Non-interventional, Observational Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan
Brief 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.
Detailed Summary:
Sponsor: Novo Nordisk A/S
Current Primary Outcome: Therapy-related thrombosis [ Time Frame: From onset of treatment until 6 hours after treatment onset ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Novo Nordisk A/S
Dates:
Date Received: May 31, 2013
Date Started: October 2014
Date Completion: June 2017
Last Updated: November 30, 2016
Last Verified: November 2016
