Weight-based Dosing in Hemophilia A
Stopped early · Phase 2
Conditions studied: Hemophilia
In brief
Hemophilia A is an inherited (genetic) disease where a protein, factor VIII (FVIII), which promotes blood clotting is missing or does not work properly. Individuals with hemophilia A are at risk for bleeding. Bleeding is prevented and/or treated with recombinant factor VIII (rFVIII), which is an FDA-approved treatment for Hemophilia A. Obesity is common among patients with hemophilia. Some studies have shown that obese hemophilia patients may be able to prevent bleeding with a lower dose of clotting factor than the dose they are currently receiving. The lower dose is calculated based on what a patient should weigh rather than what he does weigh. This is a clinical research study to test whether calculating rFVIII dosing based on lean body mass and ideal body weight (what a person should weigh based on his height) in overweight and obese patients with hemophilia is more accurate than calculating rFVIII dosing based on what a person actually weighs.
Key facts
- Study ID
- NCT02586012
- Run by
- Craig Seaman
- People needed
- 30
- Starts
- 2015-09-01
- Expected to finish
- 2020-01-10
- Last updated by the study team
- 2020-09-25
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Adult males age 18 or older.
- Hemophilia A (FVIII activity 40% or less).
- Overweight or obesity defined as a BMI of 25.0-29.9 and ≥ 30 mg/m2, respectively.
You may not qualify if…
- Prior history of, or currently detectable, FVIII inhibitor defined as greater than or equal to 0.6 Bethesda Units (BU); however, a subject with a past low-level non-responding inhibitor defined as less than 5 BU, with no increase in titer following FVIII exposure, and not detectable within 12 months of the study, despite FVIII exposure during that period, will be allowed to enroll on study.
- Allergy to FVIII products.
- Current rFVIII requirements do not include at least a 72-hour period without rFVIII administration.
Where it is running
- Hemophilia Center of Western Pennsylvania — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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