An interventional study of Ideal Body Weight First and Actual Body Weight First in Hemophilia A, sponsored by Bloodworks. Status unknown at 4 sites in United States. Open to male participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2017-09-18.
Sponsored by Bloodworks · Not applicable, Interventional, and Health services research
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.
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 and obese patients, may deliver more clotting factor than necessary to cause bleeding to stop in participants with Hemophilia A who use Factor VIII (FVIII). This study also examines ways to prevent delivering too much factor by using a participant'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 hemostatic factor levels.
The study will be conducted at the Washington Center for Bleeding Disorders (WCBD) at Bloodworks Northwest, Oregon Health \& Science University (OHSU), Seattle Children's Hospital (SCH), and Providence Sacred Heart Children's Hospital (SH). Cumulatively across the four sites, up to 20 participants will be enrolled. Randomization will be performed centrally at WCBD.
Participants will provide their own factor. Prior to the first study-related dose, participants will stop taking any FVIII products for either 48 hours if currently using a short-acting FVIII product or 72 hours for a long acting FVIII product. Factor levels will be measured immediately before and at multiple points after two different factor doses. Subjects will be randomized to start their dosage based either on actual body weight or ideal body weight first and then crossover to receive dosage based on the other category.
885 studies on the registry are indexed under Hemophilia A; 139 are open to participants now.
This study's planned enrollment of 20 is below the median of 27 across 523 interventional studies indexed under Hemophilia A.
Browse Hemophilia A studies →Bloodworks is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Randomized to receive factor product based on ideal body weight first
Other: Ideal Body Weight First
Randomized to receive factor product based on actual body weight first
Other: Actual Body Weight First
Randomized to receive 50 U/kg (+/- 20%) of the factor product participants routinely use based on ideal body weight. For participants age 12-19, ideal weight is calculated using the McLaren method. For participants age 20 and over, ideal weight is calculated using the following equation: \[50kg + (2.3kg\*every inch over 5 feet)\].
Randomized to receive 50 U/kg (+/- 20%) of the factor product participants routinely use based on actual body weight.
Recovery
Compare the recovery with FVIII between doses calculated on actual body weight versus ideal body weight in subjects with Hemophilia A
Time frame: Change from baseline at up to two months
Underdosing
Determine the likelihood of underdosing when using ideal body weight
Time frame: Change from baseline at up to two months
Overdosing
Determine the likelihood of overdosing when using actual body weight
Time frame: Change from baseline at up to two months
Effect of half-life
Determine the effect on half-life of these dosing strategies
Time frame: Change from baseline at up to two months
Effect on hemophilia severity
Determine the effect of pharmacokinetic differences on hemophilia severity
Time frame: Change from baseline at 20-40 minutes, 5-7 hours, 20-26 hours, and 44-50 hours for both half-life and extended half-life and also at 69-75 hours, and 93-99 hours for extended half-life
Regular half-life vs. extended half-life Regular half-life vs. extended half-life
Determine differences in participants receiving regular half-life versus extended half-life products
Time frame: Change from baseline at up to two months
Overweight vs. obese
Determine the differences, if any, between overweight and obese participants
Time frame: Change from baseline at up to two months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Started Jan 2017 (actual). Primary completion is estimated for Dec 2018, 23 months after the start.
Of 60 non-industry interventional studies with no phase under Hemophilia A, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 46. This study's planned 23 months is above that.
Counting every sponsor, half of 63 studies reached it within 12 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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