A Phase II Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of SR604 Injection in Patients With Von Willebrand Disease

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShanghai RAAS Blood Products Co., Ltd.

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

Treatment groups

24 Participants
are divided into 1 treatment group