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An Open-label Study To Evaluate Prophylaxis Treatment, And To Characterize The Efficacy, Safety, And Pharmacokinetics Of B-domain Deleted Recombinant Factor Viii Albumin Free (Moroctocog Alfa [Af-cc]) In Children With Hemophilia A
The purpose of this research study is to determine the effectiveness, safety, and pharmacokinetics (PK) of moroctocog alfa (AF-CC) in previously treated subjects, who are younger than 6 years of age, with severe or moderately severe hemophilia A.
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 66 |
| Start date | 2007-12 |
| Completion | 2018-04 |
Conditions
- Hemophilia A
Interventions
- Moroctocog alfa (AF-CC)
- Moroctocog alfa (AF-CC)
Primary outcomes
- Mean Annualized Bleed Rate (ABR) by Treatment: On Demand Cohort — Day 1 up to Month 6 (OD Cohort, OD Therapy, Period 1); Month 7 up to Month 18 (OD Cohort, RP 25 IU/kg, Period 2)
ABR for each participant was calculated as the number of bleeds requiring administration of moroctocog alfa (AF-CC) divided by the total therapy duration (in days), then multiplied by 365.25 (days in a year).
Countries
United States, Argentina, Austria, Colombia, Croatia, Jordan, Mexico, New Zealand, Oman, Peru, Poland, Romania, Turkey (Türkiye)