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

Completed

• Conditions: Haemophilia A; Haemophilia B; Congenital Bleeding Disorder
• Interventions: Drug: activated recombinant human factor VII

• Registration Number: NCT01220141
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2010-10-12
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-13
• Study Start: 2010-11
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 51

Inclusion Criteria

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

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Exclusion Criteria

Not provided

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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
Reduced therapeutic response and neutralising antibodies to activated recombinant human factor VII as confirmed by central laboratory	after 25 exposure days

Secondary Outcome Measures

Name	Time	Method
Adverse events reported as potentially related to activated recombinant human factor VII	after 25 exposure days