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

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).

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Key information

Conditions

Congenital Bleeding Disorder Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Haemophilia A Haemophilia B Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemophilia B Hemorrhagic Disorders

Sex eligibility

Male

Study type

Observational

Primary location

Prov. de Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

activated recombinant human factor VII

Drug

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.

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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Prospective Observational Study on NovoSeven® Room Temperature Stable (VII25) in Patients With Haemophilia A or B

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Oct 13, 2010
Registry last updated: Apr 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed