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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: |
NCT00914459 |
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Date of registration:
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04/06/2009 |
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Primary sponsor: |
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Public title:
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Study Evaluating Safety And Efficacy Of Moroctocog Alfa (AF-CC) In Previously Treated Hemophilia A Patients
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Scientific title:
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A Non-Randomized, Open-Label Study To Evaluate The Pharmacokinetics, Safety, And Efficacy Of ReFacto AF In Previously Treated Pediatric Subjects Less Than Twelve Years Of Age With Severe Hemophilia A (FVIII:C <1%) |
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Date of first enrolment:
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December 2009 |
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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/NCT00914459 |
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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, Primary Purpose: Treatment
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Countries of recruitment
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Finland
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Greece
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Italy
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Poland
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Romania
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Serbia
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Spain
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Sweden
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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 less than 12 years of age with a documented history of severe
hemophilia A (FVIII:C less than 1%).
- Subjects who are less than 6 years of age must have had at least 50 Exposure Days
(EDs) to prior FVIII products (including blood products).
- Subjects who are equal to or greater than 6 years of age must have had greater than
150 EDs to prior FVIII products (including blood products).
Exclusion Criteria:
- For laboratory assessments, any measured Bethesda inhibitor titer equal to or greater
than 0.6 BU, regardless of the laboratory normal range, or any Bethesda inhibitor
titer greater than ULN for the testing laboratory at the time of screening.
- Any other bleeding disorder in addition to hemophilia A.
- Treatment with any investigational drug or device within 30 days before the time of
signing the parental informed consent/assent form.
- Major surgery planned to occur during the course of the study.
- Regular (e.g., daily; every other day) use of agents or medications known to
influence platelet function such as aspirin or certain nonsteroidal anti-inflammatory
drugs (NSAIDS).
- Regular, concomitant therapy with immunomodulating drugs (e.g., intravenous
immunoglobulin [IVIG], routine systemic corticosteroids), or currently receiving
immune tolerance induction (ITI) for inhibitor treatment.
- The subject is receiving treatment for HIV or hepatitis infection (unless the subject
is on a stable antiviral regimen [i.e., consistent treatment regimen for at least 3
months before the parental informed consent/assent form is signed]).
- Platelet count less than 100,000/µL.
- Prothrombin time (PT) equal to or greater than 1.25 x ULN, or international
normalized ratio (INR) equal to or greater than 1.5.
- Known hypersensitivity to hamster protein.
Age minimum:
N/A
Age maximum:
11 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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Biological: Moroctocog alfa ( AF-CC)
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Procedure: Laboratory tests
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Primary Outcome(s)
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Incidence of clinically significant FVIII inhibitor development.
[Time Frame: 2 years]
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Secondary Outcome(s)
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Annualized bleeding rates (ABRs) in subjects receiving treatment with ReFacto AF.
[Time Frame: 2 years]
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Average infusion dose and total factor consumption, and the incidence of less-than-expected therapeutic effect (LETE).
[Time Frame: 2 years]
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Incidence of SAEs and nonserious AEs.
[Time Frame: 2 years]
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Number of bleeds within 48 hours of a preventive/prophylaxis dose of ReFacto AF.
[Time Frame: 2 years]
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Number of ReFacto AF infusions to treat each new bleed.
[Time Frame: 2 years]
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Responses to the first on-demand treatment with ReFacto AF for all new bleeds (4 point scale of assessment) as assessed by the parent/legal representative.
[Time Frame: 2 years]
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Secondary ID(s)
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3082B2-4433
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B1831005
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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