Study Evaluating Safety And Efficacy Of Moroctocog Alfa (AF-CC) In Previously Treated Hemophilia A Patients
NCT00914459
ABOUT THIS STUDY
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- 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).
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating Safety And Efficacy Of Moroctocog Alfa (AF-CC) In Previously Treated Hemophilia A Patients | |||
Official Title ICMJE | 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). | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Hemophilia A | |||
Intervention ICMJE |
| |||
Study Arms ICMJE | Moroctocog alfa (AF-CC)
Open Label Interventions:
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 37 | |||
Original Estimated Enrollment ICMJE | 50 | |||
Actual Study Completion Date ICMJE | April 2016 | |||
Actual Primary Completion Date | March 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | up to 11 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Finland, Georgia, Italy, Romania, Serbia, Spain, Sweden, Turkey, Ukraine | |||
Removed Location Countries | Bulgaria, Greece, Poland | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00914459 | |||
Other Study ID Numbers ICMJE | 3082B2-4433 B1831005 ( Other Identifier: Alias Study Number ) 2008-008435-29 ( EudraCT Number ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | December 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |