Comparison of Ideal vs. Actual Weight Base Factor Dosing
Status unconfirmed · Not applicable
Conditions studied: Hemophilia A
In brief
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 with Hemophilia A may deliver excessive clotting factor to achieve the desired result of bleeding prevention and cessation. This study also examines ways to prevent delivering excessive factor by using a patient's ideal body weight as a new dosing strategy compared to the current dosing strategy. The hypothesis being tested is that factor dosing based on ideal body weight will result in protective factor levels.
Key facts
- Study ID
- NCT03286153
- Run by
- Bloodworks
- People needed
- 20
- Starts
- 2017-01-01
- Expected to finish
- 2018-12-01
- Last updated by the study team
- 2017-09-18
Who can join
Age: 12 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Hemophilia A
- Able and willing to comply with pharmacokinetic testing schedule
- Either overweight or obese BMI using CDC definitions by age
You may not qualify if…
- 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
Where it is running
- Oregon Health & Science University — Portland, Oregon, United States (enrolling)
- Washington Center for Bleeding Disorders at Bloodworks Northwest — Seattle, Washington, United States (enrolling)
- Seattle Children's Hospital — Seattle, Washington, United States (enrolling)
- Providence Sacred Heart Children's Hospital — Spokane, Washington, United States (enrolling)
Full record on ClinicalTrials.gov
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