Adults (any gender) aged ≥18 years with hemophilia (any severity, with or without inhibitors) self-identified with obesity or overweight

Caregivers of children (any gender) currently aged <18 years with hemophilia (any severity, with or without inhibitors) caregiver-identified with obesity or overweight

Spouses or partners of adults (any gender) aged ≥18 years with hemophilia (any severity, with or without inhibitors) self-identified with obesity or overweight

Healthcare professional (pediatric or adult hematologist, nurse, nurse practitioner, physician assistant, physical therapist, social worker) actively working in a federally designated hemophilia-treatment center for at least 3 years and with experience managing patients with hemophilia and obesity or overweight.

Haemophilia A, Haemophilia B, Obesity

No treatment given

Novo Nordisk Investigational Site

Awareness, Care, and Treatment In Obesity Management of Patients With Hemophilia (ACTION) to Inform Hemophilia Obesity Patient Empowerment (HOPE)

Data is collected via online questionnaires

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Novo Nordisk A/S

Randomized to receive factor product based on ideal body weight first

Randomized to receive factor product based on actual body weight first

Hemophilia A

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)].

Ideal Body Weight First

Randomized to receive 50 U/kg (+/- 20%) of the factor product participants routinely use based on actual body weight.

Actual Body Weight First

Oregon Health & Science University

Washington Center for Bleeding Disorders at Bloodworks Northwest

Seattle Children's Hospital

Providence Sacred Heart Children's Hospital

Comparison of Ideal vs. Actual Weight Base Factor Dosing

Compare the recovery with FVIII between doses calculated on actual body weight versus ideal body weight in subjects with Hemophilia A

Determine the likelihood of underdosing when using ideal body weight

Determine the likelihood of overdosing when using actual body weight

Determine the effect on half-life of these dosing strategies

Determine the effect of pharmacokinetic differences on hemophilia severity

Determine differences in participants receiving regular half-life versus extended half-life products

Determine the differences, if any, between overweight and obese participants

Bloodworks

Oregon Health and Science University

Providence Health & Services

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

Subjects will be randomized to receive rFVIII doses calculated by 3 separate methods over a 3 week period. Week 1, the dose will be based on TBW (Total Body Weight); Week 2, the dose will be based on LBM (Lean Body Mass); and Week 3, the dose will be based on IBW (Ideal Body Weight).

Subjects will be randomized to receive rFVIII doses calculated by 3 separate methods over a 3 week period. Week 1, the dose will be based on LBM (Lean Body Mass); Week 2, the dose will be based on IBW (Ideal Body Weight); and Week 3, the dose will be based on TBW (Total Body Weight).

Subjects will be randomized to receive rFVIII doses calculated by 3 separate methods over a 3 week period. Week 1, the dose will be based on IBW (Ideal Body Weight); Week 2, the dose will be based on TBW (Total Body Weight); and Week 3, the dose will be based on LBM (Lean Body Mass).

Subjects will be randomized to receive rFVIII doses calculated by 3 separate methods over a 3 week period. Week 1, the dose will be based on TBW (Total Body Weight); Week 2, the dose will be based on IBW (Ideal Body Weight); and Week 3, the dose will be based on LBM (Lean Body Mass).

Subjects will be randomized to receive rFVIII doses calculated by 3 separate methods over a 3 week period. Week 1, the dose will be based on LBM (Lean Body Mass); Week 2, the dose will be based on TBW (Total Body Weight); and Week 3, the dose will be based on IBW (Ideal Body Weight).

Subjects will be randomized to receive rFVIII doses calculated by 3 separate methods over a 3 week period. Week 1, the dose will be based on, IBW (Ideal Body Weight); Week 2, the dose will be based on LBM (Lean Body Mass); and Week 3, the dose will be based on TBW (Total Body Weight).

Hemophilia

Recombinant FVIII concentrate is an FDA approved, and both efficacious and safe, therapy for the treatment and prevention of bleeding in hemophilia A. The rFVIII infusion dose will be calculated as follows: [(weight in kg x desired FVIII increase of 100 IU/dL)/(2)].

rFVIII

Hemophilia Center of Western Pennsylvania

Weight-based Dosing in Hemophilia A

Weight-based Dosing in Hemophilia A: A Randomized, Controlled, Open-label, Crossover Trial to Measure Factor VIII Recovery Following Factor VIII Concentrate Dosing Based on Total Body Weight, Ideal Body Weight, and Lean Body Mass

Desired peak FVIII recovery value of 2 +/- 0.2 IU/dl per IU/kg (100 +/- 10%) at 10 minutes following infusion based on LBM and TBW. FVIII recovery values will be calculated as follows: [(weight in kg x observed FVIII recovery in IU/dL)/(dose in IU)] and expressed as IU/dL per IU/kg.

Desired peak FVIII recovery value of 2 +/- 0.2 IU/dl per IU/kg (100 +/- 10%) at 10 minutes following infusion based on IBW and TBW. FVIII recovery values will be calculated as follows: [(weight in kg x observed FVIII recovery in IU/dL)/(dose in IU)] and expressed as IU/dL per IU/kg.

Desired peak FVIII recovery value of 2 +/- 0.2 IU/dl per IU/kg (100 +/- 10%) at 10 minutes following infusion based on LBM and IBW. FVIII recovery values will be calculated as follows: [(weight in kg x observed FVIII recovery in IU/dL)/(dose in IU)] and expressed as IU/dL per IU/kg.

hemophilia a/obesità

Awareness, Care, and Treatment In Obesity Management of Patients With Hemophilia (ACTION) to Inform Hemophilia Obesity Patient Empowerment (HOPE)

Comparison of Ideal vs. Actual Weight Base Factor Dosing

Weight-based Dosing in Hemophilia A

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