Actively Recruiting
A Study of Recombinant Von Willebrand Factor (rVWF) in Chinese Participants With Von Willebrand Disease (vWD)
Led by Takeda · Updated on 2026-01-08
20
Participants Needed
7
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Recombinant Von Willebrand Factor (rVWF) in Chinese Participants With Von Willebrand Disease (vWD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must voluntarily sign an IRB/independent ethics committee-approved informed consent after study explanation.
- Documented diagnosis of severe VWD with baseline VWF:RCo less than 20 IU/dL, confirmed per specified type criteria.
- Participant is at least 18 years old at screening.
- Participant is ethnic Chinese living in China, Taiwan, Hong Kong, or Macao.
- If female of childbearing potential, negative pregnancy test and agreement to use adequate birth control during the study.
- Willing and able to comply with study requirements.
- Minimum of 3 documented bleeds requiring VWF coagulation factor replacement therapy in the past 12 months prior to enrollment.
You will not qualify if you...
- Diagnosis of pseudo VWD or other hereditary/acquired coagulation disorders besides VWD.
- History or presence of a VWF inhibitor at screening.
- Documented history of VWF:RCo half-life less than 6 hours.
- History or presence of FVIII inhibitor with titer ≥ 0.6 Bethesda units/mL.
- Known hypersensitivity to study drug components such as mouse or hamster proteins.
- History of immunological disorders excluding mild allergies or asthma.
- History of thromboembolic events.
- HIV positive with CD4 count less than 200/mm³.
- Treatment with immunomodulatory drugs (except antiretroviral chemotherapy) or corticosteroids >10 mg/day within 30 days before consent.
- Pregnant or lactating at informed consent.
- Participation in another clinical study with investigational product or device within 30 days before or during this study.
- Progressive fatal disease or life expectancy less than 15 months.
- Member of study team or dependent of study team members.
- Acute illness at screening.
- Significant liver disease evidenced by abnormal labs or clinical signs.
- Renal disease with serum creatinine ≥ 2.5 mg/dL.
- Platelet count less than 100,000/mL at screening (except type 2B VWD with special consideration).
- Cervical or uterine conditions causing abnormal bleeding.
- Other clinically significant conditions posing additional risk.
- Unable or unwilling to cooperate with study procedures.
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Peking Union Medical College Hospital
Beijing, China, 100006
Actively Recruiting
2
Nanfang Hospital Southern Medical University
Guangzhou, China, 510515
Actively Recruiting
3
Jinan Central Hospital
Jihan, China, 250013
Actively Recruiting
4
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, China, 201801
Actively Recruiting
5
The First Affiliated Hospital of Soochow University
Suzhou, China, 215005
Actively Recruiting
6
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, China, 300052
Actively Recruiting
7
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China, 430032
Actively Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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