At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Moroctocog alfa (AF-CC) for Hemophilia A. Completed, enrolled 66 participants across 28 sites in 13 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
On-demand therapy for 6 months, followed by routine prophylaxis 25 IU/kg, administered every other day for 1 year.
Routine prophylaxis crossover: 45 IU/kg, administered 2 times a week for 1 year followed by 25 IU/kg administered every other day for 1 year, or, 25 IU/kg, administered every other day for 1 year, followed by 45 IU/kg, administered 2 times a week for 1 year.