Brief Title
Study Evaluating Safety And Efficacy Of Moroctocog Alfa (AF-CC) In Previously Treated Hemophilia A Patients
Official Title
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%).
Brief Summary
The study will be investigating pharmacokinetics, safety and efficacy in patients less than
12 years of age with severe hemophilia A that have been previously treated with Factor VIII
products ( including blood products).
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Percentage of Participants With Clinically Significant Factor VIII Inhibitor Development
Secondary Outcome
Mean Annualized Bleeding Rates (ABRs): All Participants
Condition
Hemophilia A
Intervention
Moroctocog alfa ( AF-CC)
Study Arms / Comparison Groups
Moroctocog alfa (AF-CC)
Description: Open Label
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
37
Start Date
December 2009
Completion Date
April 2016
Primary Completion Date
March 2016
Eligibility Criteria
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.
Gender
Male
Ages
N/A - 11 Years
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Location Countries
Finland
Location Countries
Finland
Administrative Informations
NCT ID
NCT00914459
Organization ID
3082B2-4433
Secondary IDs
B1831005
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
December 2016