Trial Condition(s):

Hematologic disease, Blood Coagulation Disorders

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

Bayer Identifier:

12749

ClinicalTrials.gov Identifier:

NCT00782470

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
38
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Germany

Status
Terminated
 
Locations

Hemophilia Treatment Center of Las Vegas

Las Vegas, United States, 89109

Status
Completed
 
Locations

Gulf States Hemophilia & Thrombophilia Center

Houston, United States, 77030

Status
Completed
 
Locations

Capitol Comprehensive Cancer Center

Jefferson City, United States, 65109

Status
Terminated
 
Locations

City of Hope National Medical Center

Duarte, United States, 91010

Status
Completed
 
Locations

Comprehensive Bleeding Disorder Center

Peoria, United States, 61614

Status
Completed
 
Locations

Investigative Site

Many Locations, Canada

Status
Terminated
 
Locations

University of Colorado Health Sciences Center

Denver, United States, 80262

Status
Completed
 
Locations

Cook Children's Medical Center

Fort Worth, United States, 76104

Status
Completed
 
Locations

Investigative Site

Many Locations, United Kingdom

Status
Terminated
 

Trial Design