drugset / Trial / NCT04060264
Clinical Trial of BCD-148 and Soliris® for the Treatment of Patients With Paroxysmal Nocturnal Hemoglobinuria
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eculizumab | Monoclonal antibody | 900 mg | Intravenous |