NCT00782470

Evaluation of the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Patients With Severe Hemophilia A

A Prospective, Non-interventional, Multi-center, Open-label Study to Evaluate the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Subjects With Severe Hemophilia A Receiving Prophylaxis and On-demand Treatment Regimen

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 38 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 14 Years – 29 Years
• Healthy volunteers: Not accepted

Summary

Understanding how often the bleeding events occur in the subjects who voluntarily decide to switch from prophylaxis to on-demand and in those subjects who remain on prophylaxis. Also look into the consequences of switching treatment in QoL (quality of life), development of target joints, activity level and reasons that might influence the desire to switch.

Conditions

• Hematologic Disease
• Blood Coagulation Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Recombinant Factor VIII (Kogenate, BAY 14-2222)	Subjects electing to stay on the prophylactic treatment (prospective)
BEHAVIORAL	Recombinant Factor VIII (Kogenate, BAY 14-2222)	Subjects electing to switch to on-demand treatment (prospective)
BEHAVIORAL	Recombinant Factor VIII (Kogenate, BAY 14-2222)	Subjects remaining on-demand treatment (retrospective)

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2008-10-31
• Last updated: 2014-11-03

Locations

10 sites across 4 countries: United States, Canada, Germany, United Kingdom