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

Bayer

Status

Completed

Conditions

Hematologic Disease

Blood Coagulation Disorders

Treatments

Behavioral: Recombinant Factor VIII (Kogenate, BAY 14-2222)

Study type

Observational

Funder types

Industry

Identifiers

NCT00782470

12749

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

Male

Ages

14 to 29 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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