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Main
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Note: This record shows only the 20 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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29 April 2013 |
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Main ID: |
NCT00950170 |
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Date of registration:
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29/07/2009 |
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Primary sponsor: |
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Public title:
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Study of Safety And Efficacy Of ReFacto AF In Previously Untreated Hemophilia A Patients In The Usual Care Setting
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Scientific title:
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An Open-Label Study Of The Safety And Efficacy Of ReFacto AF In Previously Untreated Patients In Usual Care Settings |
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Date of first enrolment:
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February 2010 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00950170 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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Countries of recruitment
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Austria
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France
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Germany
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Italy
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Poland
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Romania
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Spain
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Sweden
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Turkey
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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1-800-718-1021 |
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Email:
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Affiliation:
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male subjects <6 years of age with severe hemophilia A (FVIII:C <1%) based on
clinical records, including newborns.
- No prior exposure to factor products or any blood products.
Exclusion Criteria:
- Presence of any bleeding disorder in addition to hemophilia A.
- Treatment with any investigational agent or device within the past 30 days.
- Any condition(s) that compromises the ability to collect study-related observations,
or that poses a contraindication to study participation (these conditions include,
but are not limited to, inadequate medical history to assure study eligibility; and
expectation of poor adherence to study requirements).
Age minimum:
N/A
Age maximum:
5 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Hemophilia A
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Intervention(s)
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Procedure: Laboratory Tests
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Primary Outcome(s)
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Proportion of subjects who develop clinically significant FVIII inhibitors during the course of the study.
[Time Frame: 12 years (study duration)]
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Secondary Outcome(s)
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Annualized bleeding rates.
[Time Frame: 12 years (study duration)]
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Responses to the first on-demand treatment with Refacto AF for all new bleeds.
[Time Frame: 12 years (study duration)]
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The average infusion dose and total factor consumption
[Time Frame: 12 years (study duration)]
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The incidence of less-than-expected therapeutic effect (LETE).
[Time Frame: 12 years (study duration)]
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The number of bleeds within 48 hours of a prophylaxis dose of ReFacto AF.
[Time Frame: 12 years (study duration)]
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The number of ReFacto AF infusions to treat each new bleed.
[Time Frame: 12 years (study duration)]
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The number of subjects who require dose escalation of their prescribed prophylaxis regimen during their participation in this study.
[Time Frame: 12 years (study duration)]
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Secondary ID(s)
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3082B2-4434
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B1831006
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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