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RECRUITING
NCT07129343
PHASE3

A Study of Recombinant Von Willebrand Factor (rVWF) in Chinese Participants With Von Willebrand Disease (vWD)

Sponsor: Takeda

View on ClinicalTrials.gov

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.

Official title: A Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in the Treatment of Bleeding Episodes in Chinese Subjects Diagnosed With Von Willebrand Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-10-13

Completion Date

2027-11-25

Last Updated

2026-01-08

Healthy Volunteers

No

Interventions

BIOLOGICAL

VONVENDI

VONVENDI is administered by intravenous injection.

BIOLOGICAL

ADVATE

ADVATE is administered by intravenous injection.

Locations (7)

Peking Union Medical College Hospital

Beijing, China

Nanfang Hospital Southern Medical University

Guangzhou, China

Jinan Central Hospital

Jihan, China

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, China

The First Affiliated Hospital of Soochow University

Suzhou, China

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, China

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China