Recruiting

Ideal vs. Actual Weight

Sponsor:

Bloodworks

Code:

NCT03286153

Conditions

Hemophilia A

Eligibility Criteria

Sex: Male

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Ideal Body Weight First

Actual Body Weight First

Study Details

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.

Conditions

Hemophilia A

Study ID

NCT03286153

Start date

Jan, 2017

Status verified date

Sep, 2017

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 12+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Ideal Body Weight First

Randomized to receive factor product based on ideal body weight first

experimental: Actual Body Weight First

Randomized to receive factor product based on actual body weight first

Interventions

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.

Primary outcome measure

  • Recovery [ Time Frame: Change from baseline at up to two months ]
  • Underdosing [ Time Frame: Change from baseline at up to two months ]
  • Overdosing [ Time Frame: Change from baseline at up to two months ]

Central Contacts and Locations

Central contacts

Heidi Thielmann, PhD

206-689-6234hthielmann@bloodworksnw.org

Rebecca Kruse-Jarres, MD, MPH

206-689-6593RebeccaKr@BloodWorksNW.org

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239-3098

Contacts

Michael Recht, MD, PhD

503-494-8311rechtm@ohsu.edu

Washington Center for Bleeding Disorders at Bloodworks Northwest

Recruiting

Seattle, Washington, United States, 98104

Contacts

Rebecca Kruse-Jarres, MD, MPH

206-689-6593RebeccaKr@BloodWorksNW.org

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Amanda Blair, MD

206-987-2106Amanda.Blair@seattlechildrens.org

Providence Sacred Heart Children's Hospital

Recruiting

Spokane, Washington, United States, 99220-2555

Contacts

Judy Felgenhauer, MD

509-474-2777Judy.Felgenhauer@providence.org

More Information

Sponsor

Bloodworks

Last update posted

Sep 18, 2017

Last verified

Sep, 2017

Keywords

  • Hemophilia A
  • FVIII
  • Ideal body weight
  • Actual body weight

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bloodworks on 2017-09-18.