Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors

Completed

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

• Registration Number: NCT01234545
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Africa and Asia. The aim of this study is to evaluate the efficacy of home treatment of joint bleeds (haemarthrosis) with NovoSeven® (activated recombinant human factor VII) in patients with haemophilia A and B patients with inhibitors.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-03
• Study First Submitted QC: 2010-11-03
• Study First Posted: 2010-11-04
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-13
• Last Update Posted: 2014-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 35

Inclusion Criteria

• Patients with congenital haemophilia and inhibitors to factor VIII or IX
• Indication of activated recombinant human factor VII for the treatment of joint bleeding located in elbow, shoulder, wrist, hip, knee, ankle

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Exclusion Criteria

• Known or suspected allergy to study product(s) or related products
• Clinically relevant coagulation disorders other than congenital haemophilia A or B

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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
Number of bleeds managed at home	Month 8
Number of treatments resulting in the control of bleeding episode	within 9 hours after the first injection of study product
Number of treatments resulting in effective pain relief	within 9 hours after the first injection of study product

Secondary Outcome Measures

Name	Time	Method
Proportion of patient/caregivers with no need of any intervention from the physician to treat the bleeding episode at home	Month 8
Proportion of patients who used their entire treatment at home	Month 8