This is a multicenter, single-arm, open-label study. Patients with Paroxysmal Nocturnal Hemoglobinuria who had previously received and completed the HRS-5965 study well included. All eligible subjects received HRS-5965 tablets or capsules until the end of treatment in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
132
HRS-5965 tablets until the end of study treatment
HRS-5965 capsules.
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
Incidence and severity of adverse events.
Time frame: Every six months,for about 3 years
Proportion of participants achieving sustained hemoglobin levels ≥ 12 g/dL in the absence of red blood cell transfusions was assessed every half a year during treatment..
Time frame: Every six months ,for about 3 years
Proportion of participants who remain free from transfusions was assessed every half a year during treatment..
Time frame: Every six months,for about 3 years
Rate of breakthrough hemolysis was assessed every half a year during treatment
Time frame: Every six months,for about 3 years
Proportion of participants with Major Adverse Vascular Events MAVEs.
Time frame: Every six months,for about 3 years
Plasma concentration of HRS-5965.
Time frame: Start of Treatment to end of study，for about 3 years
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