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Post-marketing Safety Surveillance of NovoSeven® in Patients With Haemophilia and Inhibitors by Means of the UK Haemophilia Database

NCT ID: NCT00853086

Last Updated: 2016-11-16

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

139 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-06-30

Brief Summary

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This study is conducted in Europe. The purpose of this retrospective study is to collect additional safety information of patients with haemophilia and inhibitors who are treated with rFVIIa.

Detailed Description

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Non-interventional, retrospective data collection on standard treatments of haemophilia A and B patients with inhibitors in the UK.

Conditions

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Congenital Bleeding Disorder Haemophilia A Haemophilia B

Study Design

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Observational Model Type

COHORT

Study Groups

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A

activated recombinant human factor VII

Intervention Type DRUG

Safety data collection in connection with the use of the drug NovoSeven® in daily clinical practice

Interventions

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activated recombinant human factor VII

Safety data collection in connection with the use of the drug NovoSeven® in daily clinical practice

Intervention Type DRUG

Other Intervention Names

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NovoSeven® rFVIIa F7

Eligibility Criteria

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Inclusion Criteria

* All haemophilia A or B patients with inhibitors treated with NovoSeven are included
Eligible Sex

MALE

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

Crawley, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1130-5940

Identifier Type: OTHER

Identifier Source: secondary_id

F7HAEM-3537

Identifier Type: -

Identifier Source: org_study_id