check_circleStudy Completed
Hematologic Disease, Hemophilia A
Bayer Identifier:
11859
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
BAY14-2222 Prophylaxis and Joint Function improvement (Adults)
Trial purpose
The purpose of the study is to evaluate the effect of prophylactic treatment on the number of joint bleeds and quality of life in severe hemophilia A subjects compared to on-demand treatment in a one-group two-treatment schedule design.
In addition, the effect of prophylactic treatment on the joint function, the number of all bleeds, and on the quality of life compared to on-demand treatment and health-economic data will be assessed.
In addition, the effect of prophylactic treatment on the joint function, the number of all bleeds, and on the quality of life compared to on-demand treatment and health-economic data will be assessed.
Key Participants Requirements
Sex
MaleAge
30 - 45 YearsTrial summary
Enrollment Goal
20Trial Dates
February 2006 - March 2008Phase
Phase 4Could I Receive a placebo
NoProducts
Kogenate FS (Recombinant Factor VIII, BAY14-2222)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Sheffield, S10 2JF, United Kingdom | |
Completed | Aurora, 80045, United States | |
Completed | Houston, 77030, United States | |
Withdrawn | Madrid, 28046, Spain | |
Completed | Cardiff, CF14 4XW, United Kingdom | |
Completed | Chapel Hill, 27599, United States | |
Completed | STRASBOURG, 67098, France | |
Completed | Roma, 00161, Italy | |
Completed | Firenze, 50134, Italy | |
Completed | Pavia, 27100, Italy | |
Withdrawn | Sta. Cruz de Tenerife, 38009, Spain |
Primary Outcome
- Number of Joint Bleedsdate_rangeTime Frame:Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of All Bleedsdate_rangeTime Frame:Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)enhanced_encryptionNoSafety Issue:
- Physical Assessment Compared to On-demand Treatment as Determined by the Gilbert Scoredate_rangeTime Frame:Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment)enhanced_encryptionNoSafety Issue:
- Quality of Life Compared to On-demand Treatment as Measured by the Haemo-QoL A Questionnairedate_rangeTime Frame:Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment)enhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1Additional Information
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