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Observational Study on the Efficacy and Safety of NovoSeven® During "Real-life" Usage in Germany

NCT ID: NCT00697320

Last Updated: 2016-12-07

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

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-12-31

Brief Summary

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This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The primary aim is to observe the haemostatic efficacy of NovoSeven® treatment during routine practice in German clinics. The observational study observes patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven® for treatment of a bleeding episode or for the prevention of a bleeding when undergoing surgery or an invasive procedure.

Detailed Description

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Conditions

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Congenital Bleeding Disorder Congenital FVII Deficiency Glanzmann's Disease Acquired Bleeding Disorder Acquired Haemophilia

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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A

eptacog alfa (activated)

Intervention Type DRUG

A NON INTERVENTIONAL OBSERVATIONAL STUDY:

Doses and frequency of injections to be prescribed by the physician as a result of the normal clinical evaluation

Interventions

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eptacog alfa (activated)

A NON INTERVENTIONAL OBSERVATIONAL STUDY:

Doses and frequency of injections to be prescribed by the physician as a result of the normal clinical evaluation

Intervention Type DRUG

Other Intervention Names

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NovoSeven® F7 activated recombinant human factor VII

Eligibility Criteria

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Inclusion Criteria

* Written informed consent obtained from patient or patient's legally acceptable representative in which he agrees that the patient's pseudonymised personal data will be transferred for use in a scientific evaluation and publication
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

Mainz, , Germany

Site Status

Countries

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Germany

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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F7HAEM-1921

Identifier Type: -

Identifier Source: org_study_id