Clinical Trial: Efficacy and Safety of HRS-5965 in Patients With PNH Who Are Still Anemia After Anti-C5 Antibody Treatment
Study Status: COMPLETED
Recruit Status: COMPLETED
Condition: Paroxysmal Nocturnal Hemoglobinuria
Study Type: INTERVENTIONAL
Official Title: Multicenter, Single-arm, Open-label Phase III Study to Evaluate Efficacy and Safety of HRS-5965 Capsule in Patients With PNH Who Are Still Anemia After Anti-C5 Antibody Treatment
Brief Summary:
This trial is a multi-center, single-arm, open-label phase III clinical trial.A total of approximately 35 patients with paroxysmal nocturnal hemoglobinuria who remained anemic despite stable use of C5 complement inhibitor (eculizumab/Kevacumab) for the first 6 months before randomization were included in the study.Approximately 40% of the subjects had received at least one red blood cell (RBC) transfusion within the first 6 months before receiving the experimental intervention.Subjects who met the criteria…
Read more