This was a phase 1b/2,open label, multi-center study to assess efficacy and safety of HS-10542 in adulte patients with paroxysmal nocturnal hemoglobinuria (PNH) with signs of active hemolysis.
Men or women aged more than or equal to (≥) 18 years, and less than (≤) 75 years.
It was confirmed to be PNH during screening, and the clone size of red blood cells or/and granulocytes or/and monocytes was detected by flow cytopy ≥10%
Stable use of C5 complement inhibitor ikuzumab/covalimab for the first 6 months of random treatment
Have at least one blood transfusion record within the last 4 months, or sustain a hemoglobin level below 100g/L the last 4 months prior to screening.
Known or suspected hereditary or acquired complement deficiency
Currently active primary or secondary immunodeficiency
History of infection with pod bacteria (such as Neisseris meningitis, Streptococcus pneumoniae, etc.)
Patients with laboratory evidence of bone marrow failure (reticulocytes <100x109/L; platelets <30x109/L; neutrophils <0.5x109/L);