A Study of Recombinant Von Willebrand Factor (rVWF) in Chinese Participants With Von Willebrand Disease (vWD)
Summary
The main aim of this study is to find out if VONVENDI is safe for adult Chinese participants with VWD. The study will also check how well VONVENDI helps control bleeding with or without product ADVATE in the participants who may need elective surgery or dental procedures. In addition, the study will also examine how VONVENDI is processed by the body (known as pharmacokinetic \[PK\]) and how the drug helps the body respond or improve a condition (pharmacodynamic \[PD\]). Participants will receive an initial dose of VONVENDI of 40 to 80 international units per kilogram (IU/kg) of body weight. If a participant's baseline factor VIII (FVIII) level is not high enough to help stop bleeding, VONVENDI will be given along with 30 to 45 IU/kg of ADVATE rFVIII. Participants will be in the study for approximately 14 months. During the study, participants will be followed up at clinics or over telephone calls.
Timeline
- Start
- 2025-10-13
- Primary completion
- 2027-11-25
- Completion
- 2027-11-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vonicog Alfa | Protein / enzyme biologic | 40 iu/kg | Intravenous |
| Subject | Vonicog Alfa | Protein / enzyme biologic | 80 iu/kg | Intravenous |
| Background | ADVATE | Protein / enzyme biologic | 30 iu/kg | Intravenous |
| Background | ADVATE | Protein / enzyme biologic | 45 iu/kg | Intravenous |