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First received: November 28, 2024

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…

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