Brief Title
Comparison of Ideal vs. Actual Weight Base Factor Dosing
Official Title
Comparison of Ideal vs. Actual Weight Base Factor Dosing
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 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.
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 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.
Study Type
Interventional
Primary Outcome
Recovery
Secondary Outcome
Effect of half-life
Condition
Hemophilia A
Intervention
Ideal Body Weight First
Study Arms / Comparison Groups
Ideal Body Weight First
Description: Randomized to receive factor product based on ideal body weight first
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
20
Start Date
January 2017
Completion Date
December 2018
Primary Completion Date
December 2018
Eligibility Criteria
Inclusion Criteria: - Hemophilia A - Able and willing to comply with pharmacokinetic testing schedule - Either overweight or obese BMI using CDC definitions by age Exclusion Criteria: - 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
Gender
Male
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Rebecca Kruse-Jarres, MD, MPH, 206-689-6234, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03286153
Organization ID
BDC Ideal Body Weight Dosing
Responsible Party
Sponsor
Study Sponsor
Bloodworks
Collaborators
Seattle Children's Hospital
Study Sponsor
Rebecca Kruse-Jarres, MD, MPH, Principal Investigator, Washington Center for Bleeding Disorders at Bloodworks Northwest
Verification Date
September 2017