NTQ5082 capsules are a small molecule CFB inhibitor. This study is a multicenter, randomized, open-label, active-controlled Phase III clinical trial designed to evaluate the efficacy and safety of NTQ5082 capsules in the treatment of patients with paroxysmal nocturnal hemoglobinuria.
None
1) During the screening period, laboratory (local laboratory) results show bone marrow failure (reticulocyte count <100×109/L, or platelet count <30×109/L [must not have received platelet transfusion within 7 days prior to the laboratory test], or neutrophil count <0.5×109/L [must not have received short-acting granulocyte colony-stimulating factor within 14 days or long-acting granulocyte colony-stimulating factor within 28 days prior to the laboratory test]).
Parallel
NTQ5082 capsules 200 mg
DrugNTQ5082 capsules 200 mg
Eculizumab Injection
DrugEculizumab
Proportion of subjects with hemoglobin (HB) levels ≥120 g/L on at least three of the four measurements between Weeks 18 and 24 in the absence of red blood cell (RBC) transfusions (defined as no RBC transfusions after Week 2 (D15) until Week 24 (D169))
Proportion of subjects who had an increase in hemoglobin level ≥20 g/L from baseline on at least three of the four measurements between Weeks 18 and 24 in the absence of red blood cell transfusions (defined as no red blood cell transfusions after Week 2
Incidence and severity of adverse events
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
