Observational Registry of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-07-31

Brief Summary

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This study was conducted in Africa, Europe, the Middle-East and South America. The primary objective of this registry was to observe the use of single dose and multi-dose use of activated recombinant human factor VII 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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Study Time Perspective

PROSPECTIVE

Study Groups

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activated recombinant human factor VII

Male patients above 2 years of age with haemophilia A or B who have developed inhibitors and have been prescribed on-demand treatment of activated recombinant human factor VII at any dose for treatment of mild to moderate spontaneous bleeds

eptacog alfa (activated)

Intervention Type DRUG

Treatment of patients experiencing bleeds at the discretion of the physician/caregiver

Interventions

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eptacog alfa (activated)

Treatment of patients experiencing bleeds at the discretion of the physician/caregiver

Intervention Type DRUG

Other Intervention Names

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activated recombinant human factor VII

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with haemophilia A or B with inhibitors
* Experience mild to moderate spontaneous bleeds which require on-demand treatment and who are currently prescribed activated recombinant human factor VII
* Be able and willing to provide informed consent (or proxy consent by caregiver, if applicable), as required by local research ethics committee, governmental or regulatory authorities
* Be willing to provide information on at least one alternate contact person in the event that the patient be somehow lost-to-follow-up over the course of registry participation (not applicable if patient is withdrawn)

Exclusion Criteria

* Known hypersensitivity to the active substance or the excipients in the formulation of activated recombinant human factor VII, or to mouse, hamster or bovine protein

Eligible Sex

MALE

Accepts Healthy Volunteers

No

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

Algiers, , Algeria

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Brussels, , Belgium

Site Status

Novo Nordisk Investigational Site

Prague, , Czechia

Site Status

Novo Nordisk Investigational Site

Paris La Défense Cedex, , France

Site Status

Novo Nordisk Investigational Site

Mainz, , Germany

Site Status

Novo Nordisk Investigational Site

Rome, , Italy

Site Status

Novo Nordisk Investigational Site

Alphen aan den Rijn, , Netherlands

Site Status

Novo Nordisk Investigational Site

Warsaw, , Poland

Site Status

Novo Nordisk Investigational Site

Paço de Arcos, , Portugal

Site Status

Novo Nordisk Investigational Site

Riyadh, , Saudi Arabia

Site Status

Novo Nordisk Investigational Site

Sandton, , South Africa

Site Status

Novo Nordisk Investigational Site

Malmo, , Sweden

Site Status

Novo Nordisk Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Crawley, , United Kingdom

Site Status

Novo Nordisk Investigational Site

Caracas, , Venezuela

Site Status

Countries

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Algeria Austria Belgium Czechia France Germany Italy Netherlands Poland Portugal Saudi Arabia South Africa Sweden Turkey (Türkiye) United Kingdom Venezuela