drugset / Trial / NCT02973087
rVWF IN PROPHYLAXIS
NaSingle-groupOpen-labelPrevention
Summary
The purpose of this phase 3 study is to investigate the efficacy and safety, including immunogenicity, thrombogenicity and hypersensitivity reactions, as well as pharmacokinetics (PK), health related quality of life (HRQoL) and pharmacoeconomics of prophylactic treatment with recombinant von Willebrand factor (rVWF) (vonicog alfa) in adult participants with severe von Willebrand disease (VWD).
Timeline
- Start
- 2017-11-16
- Primary completion
- 2020-07-06
- Completion
- 2020-07-06
Publications
- Hancock JM, Escobar MA. An evaluation of von Willebrand factor (recombinant) therapy for adult patients living with severe type 3 von Willebrand disease. Expert Rev Hematol. 2023 Mar;16(3):157-161. doi: 10.1080/17474086.2023.2184339. Epub 2023 Mar 2.
- Leebeek FWG, Peyvandi F, Escobar M, Tiede A, Castaman G, Wang M, Wynn T, Baptista J, Wang Y, Zhang J, Mellgard B, Ozen G. Recombinant von Willebrand factor prophylaxis in patients with severe von Willebrand disease: phase 3 study results. Blood. 2022 Jul 14;140(2):89-98. doi: 10.1182/blood.2021014810.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vonicog Alfa | Protein / enzyme biologic | 50 iu/kg | Intravenous |
| Subject | Vonicog Alfa | Protein / enzyme biologic | 80 iu/kg | Intravenous |
| Background | ADVATE | Protein / enzyme biologic | — | Intravenous |