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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01285089 |
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Date of registration:
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26/01/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Observational Study on the Use of NovoSeven® for Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia
ACQUI-7 |
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Scientific title:
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Prospective French Study on ACQUIred Haemophilia Treatment With Recombinant Factor VIIa (NovoSeven®) A Prospective Observational Study on the Use of NovoSeven® (Activated Recombinant Human Factor VIIa) for the Haemostatic Treatment of Bleeding Episodes in Patients With Acquired Haemophilia |
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Date of first enrolment:
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December 2010 |
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Target sample size:
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21 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01285089 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Global Clinical Registry (GCR, 1452) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk A/S |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosed with acquired haemophilia
- Treated with activated recombinant human factor VII as first line treatment
- Treated with activated recombinant human factor VII after January 2011
Exclusion Criteria:
- Patients with first diagnosis before january 2010 and having a relapse after january
2011
- Known hypersensitivity to NovoSeven®, or to mouse, hamster or bovine protein
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acquired Bleeding Disorder
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Acquired Haemophilia
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Intervention(s)
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Drug: activated recombinant human factor VII
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Primary Outcome(s)
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Identification of decision criteria to treat patient with activated recombinant human factor VII
[Time Frame: Year 3]
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Secondary Outcome(s)
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Number of patients with a control of bleeding
[Time Frame: Year 3]
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Secondary ID(s)
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F7HAEM-3856
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U1111-1114-8926
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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