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

Novo Nordisk A/S36 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Congenital Bleeding Disorder Congenital FVII Deficiency

Interventions

activated recombinant human factor VIIDRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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®

Locations (1)

Unnamed facility

Tokyo, Japan

Outcomes

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

Data from ClinicalTrials.gov

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