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NCT01876745 Clinical Trial

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

Congenital Bleeding Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01876745
Other study ID # F7HAEM-4030
Secondary ID U1111-1139-9589
Status Completed
Phase N/A
First received May 31, 2013
Last updated July 10, 2017
Start date October 7, 2014
Est. completion date June 1, 2017

Study information
Verified date July 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 4
Est. completion date June 1, 2017
Est. primary completion date June 1, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• eptacog alfa (activated)
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.

Locations
Country Name City State
Japan Novo Nordisk Investigational Site Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Therapy-related thrombosis From onset of treatment until 6 hours after treatment onset
Secondary Overall efficacy evaluated by the caregiver/patient: effective, partially effective, ineffective or not possible to evaluate Within 30 days of end of treatment for bleeding episodes
Secondary Overall efficacy evaluated by the caregiver/patient: effective, partially effective, ineffective or not possible to evaluate Within 24 hours after surgery for surgery/delivery
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