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Non-Interventional Study of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors

NCT ID: NCT01586936

Last Updated: 2017-02-27

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

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-03-10

Study Completion Date

2010-03-09

Brief Summary

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This study is conducted in Japan. The aim of this registry study is to observe the use of single dose and multi-dose use of eptacog alpha (NovoSeven®) and to compare short-term outcomes, including effectiveness, safety, quality of life and treatment satisfaction with the approved treatments.

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Detailed Description

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Conditions

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Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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eptacog alpha users

eptacog alfa (activated)

Intervention Type DRUG

Prescription of eptacog alpha at the discretion of the physician

Interventions

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eptacog alfa (activated)

Prescription of eptacog alpha at the discretion of the physician

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Treated with eptacog alpha (NovoSeven®)

Exclusion Criteria

* Investigator decision to measure for antibody as unnecessary medical testing
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Countries

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Japan

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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F7-1949

Identifier Type: -

Identifier Source: org_study_id

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