Brief Title
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
Official Title
A Prospective Observational Study on the Home Treatment of Haemarthrosis With rFVIIa (Activated Recombinant Factor VII) in Haemophilia A and B Patients With Inhibitors
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) in patients with haemophilia A and B patients with inhibitors.
Study Type
Observational
Primary Outcome
Number of bleeds managed at home
Secondary Outcome
Proportion of patient/caregivers with no need of any intervention from the physician to treat the bleeding episode at home
Condition
Congenital Bleeding Disorder
Intervention
activated recombinant human factor VII
Study Arms / Comparison Groups
A
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
35
Start Date
October 2010
Completion Date
April 2012
Primary Completion Date
April 2012
Eligibility Criteria
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
Gender
Male
Ages
2 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
Algeria
Location Countries
Algeria
Administrative Informations
NCT ID
NCT01234545
Organization ID
F7HAEM-3850
Secondary IDs
U1111-1116-2488
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
November 2014