This is a multicenter, randomized, single-blind Phase II trial to evaluate the efficacy and safety of XH-S003 capsules in PNH patients. About 24 PNH patients will be enrolled and randomized to three dose levels and take XH-S003 capsules orally
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
25mg \& 100mg
TianJin Medical University General Hospital
Tianjin, China
RECRUITINGChanges of hemoglobin compared with baseline
Changes of hemoglobin compared with baseline
Time frame: 8 weeks
Proportion of subjects with an increase in Hb ≥20g/L compared with baseline (without RBC transfusion);
Proportion of subjects with an increase in Hb ≥20g/L compared with baseline (without RBC transfusion);
Time frame: 8 weeks
Changes in Indirect Bilirubin compared to baseline;
Changes in Indirect Bilirubin compared to baseline;
Time frame: 8 weeks
Changes in reticulocyte counts compared to baseline;
Changes in reticulocyte counts compared to baseline;
Time frame: 8 weeks
Proportion of subjects without RBC transfusion
Proportion of subjects without RBC transfusion
Time frame: 8 weeks
Changes in LDH compared with baseline
Changes in LDH compared with baseline
Time frame: 8 weeks
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