Observational Patient Diary Study of Treatment Doses for Patients With Haemophilia With Inhibitors to Factors VIII and IX
NCT ID: NCT00710619
Last Updated: 2016-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
52 participants
OBSERVATIONAL
2008-06-30
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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A
activated recombinant human factor VII
This is an observation of how patients/caregivers dose bypassing agents at home for haemophilia with inhibitors
Feiba VH
This is an observation of how patients/caregivers dose bypassing agents at home for hemophilia with inhibitors
Interventions
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activated recombinant human factor VII
This is an observation of how patients/caregivers dose bypassing agents at home for haemophilia with inhibitors
Feiba VH
This is an observation of how patients/caregivers dose bypassing agents at home for hemophilia with inhibitors
Eligibility Criteria
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Inclusion Criteria
* Subjects prescribed NovoSeven® as the first line or recommended bypass agent
* History of on average at least 4 bleeds of any type over a 3 month period
* Subject or caregiver able and willing to complete daily journal for 3 months
* Informed consent obtained from all subjects or legal representative
MALE
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Plainsboro, New Jersey, United States
Countries
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References
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Gruppo RA, Kessler CM, Neufeld EJ, Cooper DL. Assessment of individual dose utilization vs. physician prescribing recommendations for recombinant activated factor VII (rFVIIa) in paediatric and adult patients with congenital haemophilia and alloantibody inhibitors (CHwI): the Dosing Observational Study in Hemophilia (DOSE). Haemophilia. 2013 Jul;19(4):524-32. doi: 10.1111/hae.12113. Epub 2013 Apr 1.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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F7HAEM-1965
Identifier Type: -
Identifier Source: org_study_id