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

July 10, 2017 updated by: Novo Nordisk A/S

A Multicentre, Non-interventional, Observational 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 1000005
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with GT, who are enrolled in this study and to whom activated recombinant human factor VII (NovoSeven®) is administered in the study period, shall be included.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NovoSeven® (activated recombinant factor VII)
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.
Other Names:
  • NovoSeven®
  • activated recombinant factor VII

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Therapy-related thrombosis
Time Frame: From onset of treatment until 6 hours after treatment onset
From onset of treatment until 6 hours after treatment onset

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Within 24 hours after surgery for surgery/delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2014

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

May 31, 2013

First Submitted That Met QC Criteria

June 12, 2013

First Posted (Estimate)

June 13, 2013

Study Record Updates

Last Update Posted (Actual)

July 11, 2017

Last Update Submitted That Met QC Criteria

July 10, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F7HAEM-4030
  • U1111-1139-9589 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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