A Phase III, Randomized, Open-Label, Active controlled, Multicenter Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) not Previously Treated with Complement Inhibitors

Paroxysmal Nocturnal Hemoglobinuria (PNH)

1. Proportion of patients who achieve transfusion avoidance, 2. Proportion of patients with hemolysis control, measured by LDH <=1.5×ULN

1. Proportion of patients with breakthrough hemolysis, 2. Proportion of patients with stabilization of hemoglobin, 3. Mean change in fatigue, as assessed by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, 4. Incidence and severity of adverse events, 5. Change from baseline in targeted vital signs, 6. Change from baseline in targeted clinical laboratory test results, 7. Incidence and severity of injection-site reactions, infusion-related reactions, hypersensitivity, and infections, 8. Incidence of adverse events leading to study drug discontinuation, 9. Incidence and severity of clinical manifestations of drug-target-drug complex formation in patients who switched to crovalimab treatment from eculizumab treatment, 10. Serum concentration of crovalimab and eculizumab, 11. Prevalence and incidence of anti-drug antibodies (ADAs) to crovalimab, 12. Change over time in pharmacodynamic biomarkers, 13. Change over time in free C5 concentration in crovalimab-treated patients, 14. Observed value and absolute change from baseline to week 25 in parameters reflecting hemolysis

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

France, Germany, Lithuania, Netherlands, Poland, Portugal, Romania, Spain, Sweden