Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B

N/ACompletedNCT01220141

Novo Nordisk A/S51 enrolled

Overview

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

Enrollment

Conditions

Congenital Bleeding Disorder Haemophilia A Haemophilia B

Interventions

activated recombinant human factor VIIDRUG

Administration of room temperature stable NovoSeven® (activated recombinant human factor VII) in dosages prescribed by the treating physician according to the product labelling text approved in his country.

Eligibility

Sex: MALE

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with congenital haemophilia A or B with inhibitors to factor VIII or factor IX * Treated with room temperature stable NovoSeven®

Locations (14)

Unnamed facility

Prov. de Buenos Aires, Argentina

Unnamed facility

Vienna, Austria

Unnamed facility

Brussels, Belgium

Unnamed facility

Paris La Défense Cedex, France

Outcomes

Primary Outcomes

Reduced therapeutic response and neutralising antibodies to activated recombinant human factor VII as confirmed by central laboratory

Time frame: after 25 exposure days

Secondary Outcomes

Adverse events reported as potentially related to activated recombinant human factor VII

Time frame: after 25 exposure days

Data from ClinicalTrials.gov

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