drugset / Trial / NCT04060264

Clinical Trial of BCD-148 and Soliris® for the Treatment of Patients With Paroxysmal Nocturnal Hemoglobinuria

NCT04060264

Phase 3 Completed 28 enrolled Biocad
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This clinical study is a randomized, open-label, international, multi-center, comparative study of efficacy and safety of BCD-148 and Soliris® in PNH patients. It is planned to investigate the efficacy, safety, and immunogenicity of one-year eculizumab course in this study. PNH - Paroxysmal nocturnal hemoglobinuria

Timeline

Start
2019-04-04
Primary completion
2020-04-27
Completion
2020-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Eculizumab Monoclonal antibody 900 mg Intravenous