This is an open-label, multicenter, exploratory Phase II clinical trial designed to evaluate the efficacy, safety, and pharmacokinetic characteristics of SR604 Injection in patients with congenital coagulation Factor VII deficiency.
Age ≥12 years and ≤65 years at the time of signing the informed consent form; both genders eligible;
Clinically diagnosed with congenital coagulation Factor VII deficiency, with historical or screening FVII activity <10%, and ≥2 treated new-onset bleeding events within 3 months prior to enrollment;
No active bleeding symptoms prior to first administration of SR604 Injection;
The subject and/or legal representative and impartial witness have signed the informed consent form, indicating voluntary agreement to participate in this trial, to provide biological samples for testing as required by the protocol, and to comply with the planned study visits;
Known history of hypersensitivity to the study drug formulation or any of its components;
Intolerance to subcutaneous injection or other local skin abnormalities or dermatoses that may affect drug administration or safety assessment;
Hemoglobin <60 g/L;
Platelet count <100×10⁹/L;
Parallel
SR604
DrugSR604 will be administered as SC injection.
Treated overall Annualized Bleeding Rate (ABR)
Treated spontaneous annualized bleeding rate
Treated overall annualized joint bleeding rate
Overall annualized bleeding rate including treated and untreated bleeding events
Annualized menorrhagia bleeding rate (menstruating females only)
Single-dose pharmacokinetic (PK) parameters:Time to Peak Plasma Concentration (Tmax)
Single-dose pharmacokinetic (PK) parameters:Peak Plasma Concentration (Cmax)
Single-dose pharmacokinetic (PK) parameters:Area Under the Concentration-Time Curve from Zero to Last Quantifiable Time Point (AUC0-t)
Multiple-dose pharmacokinetic parameters-Time to Peak Plasma Concentration (Tmax)
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This trial is not recruiting at the moment. You can still explore other options:
