NCT01085344

Canadian Hemophilia Prophylaxis Study

Moderate Term Musculoskeletal Outcomes With Escalating Dose Prophylaxis: the Canadian Hemophilia Prophylaxis Study Follow-up Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: Male
• Age: 12 Months – 30 Months
• Healthy volunteers: Not accepted

Summary

Primary prophylaxis given less frequently initially, with the infusion frequency increased if needed (Escalating Dose Prophylaxis), is likely to be less expensive and associated with fewer complications than standard prophylaxis while reducing disability to a greater degree than intermittent therapy.

Detailed description

There are 2 specific study objectives. The first is to estimate the incidence of target joint bleeding in patients with severe hemophilia A treated (for primary prophylaxis) with Escalating Dose Prophylactic factor replacement. The second objective is to obtain accurate estimates of the direct and indirect costs associated with this protocol for use in a cost-effectiveness model (comparing Escalating Dose with standard prophylaxis and with intermittent therapy).

Conditions

• Severe Hemophilia A

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS)	escalating dose prophylaxis
BIOLOGICAL	Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS)	escalating dose

Timeline

• Start date: 1997-06-26
• Primary completion: 2012-12-01
• Completion: 2014-12-01
• First posted: 2010-03-11
• Last updated: 2019-12-05
• Results posted: 2019-12-05

Locations

1 site across 1 country: Canada