Observational Study on Safety and Efficacy of NovoSeven® in Subjects With Congenital FVII Deficiency

This study is conducted in Japan. The aim of this observational study is to evaluate the long-term safety and efficacy of activated recombinant human factor VII (NovoSeven®) in subjects with congenital FVII deficiency.

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Key information

Conditions

Congenital Bleeding Disorder Congenital FVII Deficiency

Sex eligibility

All sexes

Study type

Observational

Primary location

Tokyo, 1000005, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Congenital FVII deficiency
Never been treated with NovoSeven® before
Patients already in treatment with NovoSeven®

Exclusion criteria

History of hypersensitivity to any of the components in NovoSeven®

Treatment and study plan

activated recombinant human factor VII

Drug

Data will be collected at the baseline visit and approximately once a year until end of study.

Primary outcomes

Presence and/or the appearance of inhibiting antibodies to factor VII and/or therapy-related thrombosis on using NovoSeven® under normal clinical practice conditions

Time frame: once a year in years 1-4

Secondary outcomes

To assess the treatment evaluation for bleeding episodes

Time frame: year 1, year 4
To assess the course and outcome of pregnancy in women treated with novoseven

Time frame: until 1 month after giving birth

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Congenital FVII Deficiency - Registry for All Treated Patients

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Mar 11, 2011
Registry last updated: Oct 20, 2014

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