Status:
UNKNOWN
Comparison of Ideal vs. Actual Weight Base Factor Dosing
Lead Sponsor:
Bloodworks
Collaborating Sponsors:
Seattle Children's Hospital
Oregon Health and Science University
Conditions:
Hemophilia A
Eligibility:
MALE
12+ years
Phase:
NA
Brief Summary
This is a randomized, prospective, multicenter study to examine whether or not the current recommended factor dosing strategy - i.e., dosing by actual body weight - in overweight and obese patients wi...
Detailed Description
This is a randomized, prospective, multicenter, open-label, crossover study to examine whether or not the current recommended factor dosing strategy, i.e., dosing by actual body weight in overweight a...
Eligibility Criteria
Inclusion
- Hemophilia A
- Able and willing to comply with pharmacokinetic testing schedule
- Either overweight or obese BMI using CDC definitions by age
Exclusion
- Inhibitor of \> 0.6 BU twice in the past, or documented abnormal recovery of less than 66% (of expected) in the past
- Known other bleeding disorder
- Known other prolongation in aPTT (lupus anticoagulant, FXII deficiency)
- Female
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03286153
Start Date
January 1 2017
End Date
December 1 2018
Last Update
September 18 2017
Active Locations (4)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239-3098
2
Washington Center for Bleeding Disorders at Bloodworks Northwest
Seattle, Washington, United States, 98104
3
Seattle Children's Hospital
Seattle, Washington, United States, 98105
4
Providence Sacred Heart Children's Hospital
Spokane, Washington, United States, 99220-2555