Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors

NCT ID: NCT01234545

Last Updated: 2014-11-14

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

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-04-30

Brief Summary

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This trial is conducted in Africa and Asia. The aim of this study is to evaluate the efficacy of home treatment of joint bleeds (haemarthrosis) with NovoSeven® (activated recombinant human factor VII) in patients with haemophilia A and B patients with inhibitors.

Detailed Description

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Conditions

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Congenital Bleeding Disorder Haemophilia A Haemophilia B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A

activated recombinant human factor VII

Intervention Type DRUG

Prescription is done at the discretion of the prescribing physician as part of normal clinical routine

Interventions

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activated recombinant human factor VII

Prescription is done at the discretion of the prescribing physician as part of normal clinical routine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with congenital haemophilia and inhibitors to factor VIII or IX
* Indication of activated recombinant human factor VII for the treatment of joint bleeding located in elbow, shoulder, wrist, hip, knee, ankle

Exclusion Criteria

* Known or suspected allergy to study product(s) or related products
* Clinically relevant coagulation disorders other than congenital haemophilia A or B
Minimum Eligible Age

2 Years

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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Algiers, , Algeria

Site Status

Casablanca, , Morocco

Site Status

Muscat, , Oman

Site Status

Riyadh, , Saudi Arabia

Site Status

Dubai, , United Arab Emirates

Site Status

Countries

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Algeria Morocco Oman Saudi Arabia United Arab Emirates

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1116-2488

Identifier Type: OTHER

Identifier Source: secondary_id

F7HAEM-3850

Identifier Type: -

Identifier Source: org_study_id