Comparison of Ideal vs. Actual Weight Base Factor Dosing
NCT ID: NCT03286153
Last Updated: 2017-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
20 participants
INTERVENTIONAL
2017-01-31
2018-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ideal Body Weight First
Randomized to receive factor product based on ideal body weight first
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: \[50kg + (2.3kg\*every inch over 5 feet)\].
Actual Body Weight First
Randomized to receive factor product based on actual body weight first
Actual Body Weight First
Randomized to receive 50 U/kg (+/- 20%) of the factor product participants routinely use based on actual body weight.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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: \[50kg + (2.3kg\*every inch over 5 feet)\].
Actual Body Weight First
Randomized to receive 50 U/kg (+/- 20%) of the factor product participants routinely use based on actual body weight.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Able and willing to comply with pharmacokinetic testing schedule
* Either overweight or obese BMI using CDC definitions by age
Exclusion Criteria
* Known other bleeding disorder
* Known other prolongation in aPTT (lupus anticoagulant, FXII deficiency)
* Female
12 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seattle Children's Hospital
OTHER
Oregon Health and Science University
OTHER
Providence Health & Services
OTHER
Bloodworks
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rebecca Kruse-Jarres, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Washington Center for Bleeding Disorders at Bloodworks Northwest
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Oregon Health & Science University
Portland, Oregon, United States
Washington Center for Bleeding Disorders at Bloodworks Northwest
Seattle, Washington, United States
Seattle Children's Hospital
Seattle, Washington, United States
Providence Sacred Heart Children's Hospital
Spokane, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form: Main
Document Type: Informed Consent Form: Consent/Assent SC
Document Type: Informed Consent Form: Assent Age 15 to 17
Document Type: Informed Consent Form: Assent Age 7 to 14
Document Type: Study Protocol
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BDC Ideal Body Weight Dosing
Identifier Type: -
Identifier Source: org_study_id