A study of the efficacy and safety of HRS-5965 capsules compared to eculizumab for 24 weeks in patients with PNH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
HRS-5965 capsule for 24 weeks
Eculizumab Injection for 24 weeks
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
The Blood Disease Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Proportion of subjects with the hemoglobin levels are ≥ 12 g/dL at least on three out of four measurements in the absence of red blood cell transfusions
Time frame: 24 weeks
Proportion of subjects with the change from baseline in hemoglobin is ≥ 2 g/dL at least on three out of four measurements in the absence of red blood cell transfusions
Time frame: 24 weeks
Proportion of subjects who absence of administration of red blood cell transfusions
Time frame: 24 weeks
Mean change from baseline in hemoglobin
Time frame: 24 weeks
Mean percent change from baseline in LDH levels
Time frame: 24 weeks
Mean change from baseline in reticulocyte counts
Time frame: 24 weeks
Mean change from baseline in FACIT-Fatigue scores
Time frame: 24 weeks
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