Status:

COMPLETED

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

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Congenital Bleeding Disorder

Haemophilia A

Eligibility:

MALE

2+ years

Brief Summary

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)...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

October 1 2010

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 1 2012

Estimated Enrollment :

35 Patients enrolled

Trial Details

Trial ID

NCT01234545

Start Date

October 1 2010

End Date

April 1 2012

Last Update

November 14 2014

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Algiers, Algeria, 16035

2

Casablanca, Morocco, 20000

3

Muscat, Oman

4

Riyadh, Saudi Arabia, 3542