drugset / Trial / NCT00717626

Once-A-Day Prophylaxis for Youth and Young Adults With Severe Hemophilia A

NCT00717626

Phase 2 Completed 14 enrolled The Hospital for Sick Children
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is to test the feasibility of a large-scale clinical trial of once-daily prophylaxis. The secondary objectives are to collect clinical efficacy outcomes so that we can better plan a large-scale study; we will estimate the effect size and variability of effect and resource utilization of once-daily prophylaxis to allow us to set a sample size for a definitive trial.

Timeline

Start
2008-07
Primary completion
2011-04
Completion
2011-04

Drugs

EvaluationDrugModalityDoseRoute
Subject ADVATE Protein / enzyme biologic 250 iu
Subject ADVATE Protein / enzyme biologic 500 iu
Subject Wilate Protein / enzyme biologic 250 iu
Subject Wilate Protein / enzyme biologic 500 iu

Indications