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

Completed

Conditions studied: Hematologic Disease, Blood Coagulation Disorders

In brief

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.

Key facts

Study ID

NCT00782470

Run by

Bayer

People needed

38

Starts

2007-12-01

Expected to finish

2010-11-01

Last updated by the study team

2014-11-03

Who can join

Age: 14 and older, up to 29. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Severe hemophilia A (<2%)
• For subjects who elect staying on Prophylaxis only: Have been on continuous prophylactic treatment for the past 5 years prior to study entry
• For subjects who elect switching to on-demand only: Have been on continuous prophylactic treatment for the past 5 years, but may have been on intermediate or reduced prophylaxis for the 1-12 months prior to study entry
• For subjects currently on-demand: a retrospective arm of subjects who have been on continuous prophylactic treatment for at least 5 years and switched to on-demand treatment between 13 and 24 months prior to study entry
• Current treatment with rFVIII

You may not qualify if…

• Other known hematological / bleeding disorders other than hemophilia A
• Participating on another study that may have an impact on bleeding or the objectives of this study
• Known alcohol and drug abuse

Where it is running

• Study site — Duarte, California, United States
• Study site — Denver, Colorado, United States
• Study site — Peoria, Illinois, United States
• Study site — Jefferson City, Missouri, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Fort Worth, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Many Locations, Canada
• Study site — Many Locations, Germany
• Study site — Many Locations, United Kingdom

Full record on ClinicalTrials.gov

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