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.
Participant must voluntarily sign an institutional review board (IRB)/independent ethics committee-approved written informed consent form after all relevant aspects of the study have been explained and discussed with the participant.
Type 1 (von Willebrand factor:Ristocetin cofactor activity [VWF:RCo] <20 IU/dL and by VWF activity/VWF:antigen [Ag] ratio) or,
Type 2A or type 2B (by VWF activity/VWF:Ag ratio and multimer pattern, with genetics if necessary), type 2N (FVIII:C <10% and genetics), type 2M (by VWF activity/VWF:Ag ratio and multimer pattern) or
Type 3 (VWF:Ag <=3 IU/dL). Diagnosis is confirmed, when applicable, by genetic testing and/or by multimer analysis.
Participant has been diagnosed with pseudo VWD or another hereditary or acquired coagulation disorder other than VWD (example [eg], qualitative and quantitative platelet disorders or elevated prothrombin time [PT]/international normalized ratio >1.4).
Participant has a history or presence of a VWF inhibitor at screening.
Participant has a documented history of a VWF:RCo half-life of <6 hours.
Participant has a history or presence of a FVIII inhibitor with a titer greater than or equal to [>=] 0.6 Bethesda units per milliliter [BU/mL] (by Bethesda assay or Bethesda method with Nijmegen modification).
Single group
VONVENDI
Biological/VaccineVONVENDI is administered by intravenous injection.
ADVATE
Biological/VaccineADVATE is administered by intravenous injection.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. An SAE is any untoward medical occurrence that at any dose: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event in the opinion of the healthcare provider, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. TEAEs consist of both serious and non-serious adverse events.
Number of Participants With TEAEs by Severity
Number of participants with severity of TEAE will be reported.
Number of Participants With TEAEs and SAEs by Causality
Number of participants with causality related TEAEs and SAEs will be reported.
Number of Participants With Thromboembolic Events and Severe Hypersensitivity Reactions
Number of participants with thromboembolic events and severe hypersensitivity reactions will be reported.
Number of Infusions of VONVENDI With or Without ADVATE per Bleeding Episode
Number of infusions of VONVENDI with or without ADVATE per bleeding episode will be reported.
Number of Infusions of ADVATE per Bleeding Episode
Number of infusions of ADVATE per bleeding episode will be reported.
Weight-adjusted Consumption of VONVENDI and ADVATE per Bleeding Episode
Weight-adjusted consumption of VONVENDI and ADVATE per bleeding episode will be reported.
Time to Resolution of Bleeding Episodes
Time to resolution of the bleeding episodes will be calculated as the difference between the date/time of the first IP infusion for the bleeding episode to the date/time of the bleeding episode resolution.
