check_circleStudy Completed
Hematologic Disease, Blood Coagulation Disorders
Bayer Identifier:
12749
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Evaluation of the Reasons and Consequences of Bleeding in Late Teens and Early Adulthood Patients With Severe Hemophilia A
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.
Key Participants Requirements
Sex
MaleAge
14 - 29 YearsTrial summary
Enrollment Goal
38Trial Dates
December 2007 - November 2010Phase
N/ACould I Receive a placebo
NoProducts
Kogenate FS (Recombinant Factor VIII, BAY14-2222)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Terminated | Many Locations, Germany | |
Completed | Hemophilia Treatment Center of Las Vegas | Las Vegas, 89109, United States |
Completed | Gulf States Hemophilia & Thrombophilia Center | Houston, 77030, United States |
Terminated | Capitol Comprehensive Cancer Center | Jefferson City, 65109, United States |
Completed | City of Hope National Medical Center | Duarte, 91010, United States |
Completed | Comprehensive Bleeding Disorder Center | Peoria, 61614, United States |
Terminated | Many Locations, Canada | |
Completed | University of Colorado Health Sciences Center | Denver, 80262, United States |
Completed | Cook Children's Medical Center | Fort Worth, 76104, United States |
Terminated | Many Locations, United Kingdom |
Primary Outcome
- To evaluate the frequency of all bleeds (spontaneous and trauma) during the studydate_rangeTime Frame:End of Studyenhanced_encryptionNoSafety Issue:
Secondary Outcome
- To evaluate the change from baseline in HRQoL (health-related quality of life)date_rangeTime Frame:End of Studyenhanced_encryptionNoSafety Issue:
- To evaluate number of patients that want to return to prophylaxis treatment after having switched to on-demand therapydate_rangeTime Frame:End of Studyenhanced_encryptionNoSafety Issue:
- To evaluate the change from baseline in the Gilbert scoredate_rangeTime Frame:End of Studyenhanced_encryptionNoSafety Issue:
- To evaluate the number of target joint developmentdate_rangeTime Frame:End of Studyenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
BehavioralTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A