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NCT07711158
A Phase II Exploratory Study of SR604 Injection Evaluating the Safety and Efficacy in the Treatment of Congenital Coagulation Factor VII Deficiency
Conditions: Factor VII Deficiency
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 12
Sponsor: Shanghai RAAS Blood Products Co., Ltd.
Location: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences Tianjin
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1. Age ≥12 years and ≤65 years at the time of signing the informed consent form; both genders eligible;
2. Clinically diagnosed with congenital coagulation Factor VII deficiency, with historical or screening FVII activity \
Source: ClinicalTrials.gov (NCT07711158). StuddyBuddy aggregates publicly available trial information.
