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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-07

Study Completion Date

2017-06-01

Brief Summary

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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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Detailed Description

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Conditions

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Congenital Bleeding Disorder Glanzmann's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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NovoSeven® (activated recombinant factor VII)

eptacog alfa (activated)

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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activated recombinant factor VII NovoSeven®

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No