Comparison of Ideal vs. Actual Weight Base Factor Dosing
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|ClinicalTrials.gov Identifier: NCT03286153|
Recruitment Status : Unknown
Verified September 2017 by Bloodworks.
Recruitment status was: Recruiting
First Posted : September 18, 2017
Last Update Posted : September 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hemophilia A||Other: Ideal Body Weight First Other: Actual Body Weight First||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Subjects are randomized to receive factor based either on ideal body weight or actual body weight first followed by receiving factor based on the other category next|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Comparison of Ideal vs. Actual Weight Base Factor Dosing|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Ideal Body Weight First
Randomized to receive factor product based on ideal body weight first
Other: Ideal 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)].
Experimental: Actual 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 actual body weight.
- Recovery [ Time Frame: Change from baseline at up to two months ]Compare the recovery with FVIII between doses calculated on actual body weight versus ideal body weight in subjects with Hemophilia A
- Underdosing [ Time Frame: Change from baseline at up to two months ]Determine the likelihood of underdosing when using ideal body weight
- Overdosing [ Time Frame: Change from baseline at up to two months ]Determine the likelihood of overdosing when using actual body weight
- Effect of half-life [ Time Frame: Change from baseline at up to two months ]Determine the effect on half-life of these dosing strategies
- Effect 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 ]Determine the effect of pharmacokinetic differences on hemophilia severity
- Regular half-life vs. extended half-life Regular half-life vs. extended half-life [ Time Frame: Change from baseline at up to two months ]Determine differences in participants receiving regular half-life versus extended half-life products
- Overweight vs. obese [ Time Frame: Change from baseline at up to two months ]Determine the differences, if any, between overweight and obese participants
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03286153
|Contact: Heidi Thielmann, PhDemail@example.com|
|Contact: Rebecca Kruse-Jarres, MD, MPH||206-689-6593||RebeccaKr@BloodWorksNW.org|
|United States, Oregon|
|Oregon Health & Science University||Recruiting|
|Portland, Oregon, United States, 97239-3098|
|Contact: Michael Recht, MD, PhD 503-494-8311 firstname.lastname@example.org|
|United States, Washington|
|Washington Center for Bleeding Disorders at Bloodworks Northwest||Recruiting|
|Seattle, Washington, United States, 98104|
|Contact: Rebecca Kruse-Jarres, MD, MPH 206-689-6593 RebeccaKr@BloodWorksNW.org|
|Seattle Children's Hospital||Recruiting|
|Seattle, Washington, United States, 98105|
|Contact: Amanda Blair, MD 206-987-2106 Amanda.Blair@seattlechildrens.org|
|Providence Sacred Heart Children's Hospital||Recruiting|
|Spokane, Washington, United States, 99220-2555|
|Contact: Judy Felgenhauer, MD 509-474-2777 Judy.Felgenhauer@providence.org|
|Principal Investigator:||Rebecca Kruse-Jarres, MD, MPH||Washington Center for Bleeding Disorders at Bloodworks Northwest|