About this trial
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamic (PD) of SR604 in patients with von Willebrand disease.
Eligibility criteria
Qualifiers
Age >= 18 years and <= 65 years at the time of signing informed consent, regardless of sex;
At screening, patients with a confirmed diagnosis of von Willebrand disease (VWD) with documented evidence and a defined VWD subtype;
At least 4 new bleeding episodes within 6 months prior to screening;
No active bleeding symptoms prior to the first dose;
Disqualifiers
Known history of hypersensitivity to the investigational drug formulation or any of its components;
Intolerance to subcutaneous injection or presence of other local skin abnormalities or dermatological conditions that may affect drug administration and safety assessment;
Hemoglobin < 60 g/L;
Platelet count < 80 x 10^9/L;
Trial design
Treatments tested in this trial
- SR604