Clinical Trial – rFVIII – Hemophilia

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University of Pittsburgh is running a clinical trial to test a drug called rFVIII to treat hemophilia. Hemophilia A is an inherited (genetic) disease where a protein, factor VIII (FVIII), which promotes blood clotting is missing or does not work properly. Bleeding is prevented and/or treated with recombinant factor VIII (rFVIII), which is an FDA-approved treatment for Hemophilia A. Obesity is common among patients with hemophilia. Some studies have shown that obese hemophilia patients may be able to prevent bleeding with a lower dose of clotting factor than the dose they are currently receiving. The lower dose is calculated based on what a patient should weigh rather than what he does weigh. This is a clinical research study to test whether calculating rFVIII dosing based on lean body mass and ideal body weight (what a person should weigh based on his height) in overweight and obese patients with hemophilia is more accurate than calculating rFVIII dosing based on what a person actually weighs. The drug is rFVIII.
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018
Contacts
Contact: Craig Seaman, MD, MS 412-209-7280 seamanc@upmc.edu
NCT Number
NCT number: NCT02586012
For enrollment please visit www.clinicaltrials.gov.
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