This is a multicenter, open-label study to evaluate the long-term safety and efficacy of XH-S003 capsules in PNH patients. About 26 PNH patients who had received and completed XH-S003 study treatment will be enrolled to take XH-S003 capsules orally according to protocol. Eligible subjects can maintain XH-S003 treatment until the end of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Optimized dose
TianJin Medical University General Hospital
Tianjin, Jinan, China
Incidence and severity of adverse events
Time frame: through study completion,an average of 1 year
Proportion of subjects with Hb ≥120g/L compared with baseline (without RBC transfusion)
Time frame: through study completion,an average of 1 year
Change From Baseline in Hemoglobin in the absence of red blood cell transfusions
Time frame: through study completion,an average of 1 year
Proportion of participants who remain free from transfusions
Time frame: through study completion,an average of 1 year
Proportion of participants with breakthrough hemolysis (BTH)
Time frame: through study completion,an average of 1 year
Proportion of participants with Major Adverse Vascular Events (MAVEs)
Time frame: through study completion,an average of 1 year
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