This is a multicenter, randomized, open-label phase II clinical trial. A total of 24 patients with paroxysmal nocturnal hemoglobinuria naïve to complement inhibitor therapy were included. Subjects were treated with HRS-5965 for 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
HRS-5965 tablets for 12 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
Changes in hemoglobin.
Time frame: 12 weeks
Changes in LDH.
Time frame: 12 weeks
Changes in haptoglobin.
Time frame: 12 weeks
Changes in bilirubin.
Time frame: 12 weeks
Changes in reticulocyte counts.
Time frame: 12weeks
Changes in C3 complement fragment deposition.
Time frame: 12 week
Percentage of patients who did not receive a blood transfusion.
Time frame: 12 weeks
Number of RBC units of transfused.
Time frame: 12weeks
Incidence and severity of adverse events
Time frame: 16 weeks
Incidence of thromboembolic events.
Time frame: 16 weeks
Plasma concentration of HRS-5965.
Time frame: 12 weeks
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