Status:

COMPLETED

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

Lead Sponsor:

Bayer

Conditions:

Hematologic Disease

Blood Coagulation Disorders

Eligibility:

MALE

14-29 years

Brief 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 con...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 1 2007

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 1 2010

Estimated Enrollment :

38 Patients enrolled

Trial Details

Trial ID

NCT00782470

Start Date

December 1 2007

End Date

November 1 2010

Last Update

November 3 2014

Active Locations (10)

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Page 1 of 3 (10 locations)

1

Duarte, California, United States, 91010

2

Denver, Colorado, United States, 80262

3

Peoria, Illinois, United States, 61614

4

Jefferson City, Missouri, United States, 65109