The purpose of this study is to evaluate the efficacy and safety of HSK39297 tablets compared to eculizumab in Patients with PNH who Are Naive to Complement Inhibitor Therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
73
200mg QD for 24 weeks
Eculizumab Injection for 24 weeks
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Proportion of participants achieving hemoglobin levels ≥ 12 g/dL at least on three out of four measurements in the absence of red blood cell transfusions
Time frame: Between Week 18 and Week 24
Proportion of participants with increase in hemoglobin levels from baseline of ≥20 g/L at least on three out of four measurements in the absence of red blood cell transfusions
Time frame: Between Week 18 and Week 24
Proportion of participants who did not receive blood transfusion.
Time frame: Between Week 2 and Week 24
Change from baseline in hemoglobin
Time frame: Baseline, week 18 to 24
Change From Baseline in Reticulocyte Count
Time frame: Baseline, week 18 to 24
Percent change from baseline in LDH
Time frame: Baseline, week 18 to 24
Change from baseline in FACIT-Fatigue score
Time frame: Baseline, week 18 to 24
Rate of breakthrough hemolysis (BTH)
Time frame: 24 weeks
Proportion of participants with Major Adverse Vascular Events (MAVEs)
Time frame: 24 weeks
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