Status:
COMPLETED
Study of Safety And Efficacy Of ReFacto AF In Previously Untreated Hemophilia A Patients In The Usual Care Setting
Lead Sponsor:
Pfizer
Conditions:
Hemophilia A
Eligibility:
MALE
Up to 6 years
Phase:
PHASE4
Brief Summary
Study to evaluate the safety and effectiveness of ReFacto AF for the treatment of severe hemophilia A in patients who have not yet received treatment for their hemophilia. Study subjects will be males...
Detailed Description
Regulatory Commitment
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 10 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2016
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00950170
Start Date
February 10 2010
End Date
November 24 2016
Last Update
July 19 2019
Active Locations (11)
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1
CHU de Nantes
Nantes, France, 44093
2
Medizinische Hochschule, Hannover
Hanover, Lower Saxony, Germany, 30625
3
Klinikum Bremen-Mitte gGmbH, Professor Hess Kinderklinik
Bremen, Germany, 28177
4
Agenzia per L'emofilia e Centro Regionale Riferimento Coagulopatie Congenite
Florence, Italy, 50134