Clinical Study
BAX 111 rVWF in Pediatrics
The purpose of the study is to look at how well recombinant von Willebrand Factor (rVWF) (the study drug) works to control bleeding that is not caused by surgery. The study will involve children with severe von Willebrand disease (VWD), and we hope to learn how safe the study drug is and how well it is accepted. The study will also look at how safe the study drug is and how well it works during surgery. Finally, the study will look at how childrens bodies process the study drug. This is a Phase 3 study, which means the study drug has already been given to other patients in other studies. In a Phase 3 study the new drug is tested longer and on more people.
For more information contact:
Kat Termath
katherine.termath@hsc.utah.edu
801-587-7759
IRB#: IRB_00099444
| PI: Jessica Meznarich
| Department: PEDIATRIC HEMATOLOGY/ONCOLOGY
| Approval Date: 2017-07-05 06:00:00
Specialties: Pediatric Hematology & Oncology
Who can participate?
Gender: All
Age: Under 18 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria:
- Diagnosis of severe VWD (defined as VWF:RCo <20%): a. Type 1 (VWF:RCo <20 IU/dL); or b. Type 2A (VWF:RCo <20 IU/dL), Type 2B (as diagnosed by genotype), Type 2N (FVIII:C <10% and historically documented genetics), Type 2M; or c. Type 3 (VWF:Ag 3 IU/dL).
Will I be paid for my time?
Yes