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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01312636

Enrollment

Registered

2011-03-11

Start date

2011-03-31

Completion date

2014-09-30

Last updated

2014-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Bleeding Disorder, Congenital FVII Deficiency

Brief summary

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.

Interventions

DRUGactivated recombinant human factor VII

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

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Healthy volunteers

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®

Design outcomes

Primary

Measure	Time frame
Presence and/or the appearance of inhibiting antibodies to factor VII and/or therapy-related thrombosis on using NovoSeven® under normal clinical practice conditions	once a year in years 1-4

Secondary

Measure	Time frame
To assess the treatment evaluation for bleeding episodes	year 1, year 4
To assess the course and outcome of pregnancy in women treated with novoseven	until 1 month after giving birth

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026