Efficacy and Safety of Elizaria® vs. Soliris® in Patients With PNH

PHASE3CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

November 29, 2017

Primary Completion Date

October 16, 2018

Study Completion Date

October 16, 2018

Conditions
Paroxysmal Nocturnal HemoglobinuriaMarchiafava-Micheli SyndromeParoxysmal Hemoglobinuria
Interventions
BIOLOGICAL

Elizaria®

Induction cycle: 600 mg (2 vials of 30 mL, 10 mg/mL) intravenous infusion for 30 minutes once a week for 4 weeks. Maintenance therapy: 900 mg (3 vials of 30 mL, 10 mg/mL) intravenous infusion for 30 minutes in Week 5, followed by 900 mg every 14 days.

BIOLOGICAL

Soliris®

Induction cycle: 600 mg (2 vials of 30 mL, 10 mg/mL) intravenous infusion for 30 minutes once a week for 4 weeks. Maintenance therapy: 900 mg (3 vials of 30 mL, 10 mg/mL) intravenous infusion for 30 minutes in Week 5, followed by 900 mg every 14 days.

Trial Locations (4)

125167

Federal State Budget Funded Institution National Medical Research Center of Hematology, Ministry of Health of the Russian Federation (MoH of Russia), Moscow

125284

Moscow State Budget Funded Healthcare Institution S. P. Botkin City Clinical Hospital, Moscow Department of Healthcare, Moscow

197022

State Budget Funded Institution of Higher Education Academician I. P. Pavlov Saint-Petersburg State Medical University of the Ministry of Health of the Russian Federation, Saint Petersburg

443079

State Budgetary Educational Institution of Higher Professional Education Samara State Medical University, Ministry of Health of the Russian Federation., Samara

All Listed Sponsors
lead

AO GENERIUM

INDUSTRY

NCT04463056 - Efficacy and Safety of Elizaria® vs. Soliris® in Patients With PNH | Biotech Hunter | Biotech Hunter