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
For enrollment please visit www.clinicaltrials.gov.
