Brief Title
Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B
Official Title
Prospective Observational Study on NovoSeven® Room Temperature Stable (VII25) in Patients With Haemophilia A or B
Brief Summary
This study is conducted in Europe and Asia. The aim of this observational study is to monitor antibody formation towards the room temperature stable formulation of NovoSeven® (activated recombinant human factor VII).
Study Type
Observational
Primary Outcome
Reduced therapeutic response and neutralising antibodies to activated recombinant human factor VII as confirmed by central laboratory
Secondary Outcome
Adverse events reported as potentially related to activated recombinant human factor VII
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
51
Start Date
November 2010
Completion Date
March 2015
Primary Completion Date
March 2015
Eligibility Criteria
Inclusion Criteria: - Diagnosed with congenital haemophilia A or B with inhibitors to factor VIII or factor IX - Treated with room temperature stable NovoSeven®
Gender
Male
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
Argentina
Location Countries
Argentina
Administrative Informations
NCT ID
NCT01220141
Organization ID
NN7025-3601
Secondary IDs
U1111-1116-2012
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
April 2015