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Study to Evaluate the Efficacy and Safety of REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Paroxysmal Nocturnal Hemoglobinuria (PNH) Clinical Trial

Official title:
An Open-Label, Single Arm Study to Evaluate the Efficacy and Safety of REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Are Complement Inhibitor-Naive or Have Not Recently Received Complement Inhibitor Therapy

Clinical Trial Summary

The primary objective of the study is to demonstrate a reduction in intravascular hemolysis by REGN3918 over 26 weeks of treatment in patients with active PNH who are treatment-naive to complement inhibitor therapy or have not recently received complement inhibitor therapy. The secondary objectives of the study are: - To evaluate the safety and tolerability of REGN3918. - To evaluate the effect of REGN3918 on parameters of intravascular hemolysis - To assess the concentrations of total REGN3918 in serum. - To evaluate the incidence of treatment-emergent anti-drug antibodies to REGN3918 over time - To evaluate the effect of REGN3918 on patient-reported outcomes (PROs) measuring fatigue and health-related quality of life

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03946748
Study type Interventional
Source Regeneron Pharmaceuticals
Contact
Status Completed
Phase Phase 2
Start date May 16, 2019
Completion date June 10, 2021
View Details
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