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

Completed

• Conditions: Congenital FVII Deficiency; Congenital Bleeding Disorder
• Interventions: Drug: activated recombinant human factor VII

• Registration Number: NCT01312636
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-02
• Study First Submitted QC: 2011-03-10
• Study First Posted: 2011-03-11
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-17
• Last Update Posted: 2014-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

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Exclusion Criteria

• History of hypersensitivity to any of the components in NovoSeven®

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	activated recombinant human factor VII	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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