NCT04463056

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

A Multicenter, Open Label, Randomized, Parallel-group Study of Efficacy and Safety of Eculizumab (JSC GENERIUM, Russia) vs. Soliris® (Alexion Pharma GmbH, Switzerland) in Patients With Paroxysmal Nocturnal Hemoglobinuria

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: AO GENERIUM · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

It is a multicenter, open-label, randomized, parallel-group study of the efficacy and safety of Elizaria® (eculizumab, GENERIUM JSC, Russia) versus Soliris® (Alexion Pharma GmbH, Switzerland) in patients with paroxysmal nocturnal hemoglobinuria.

Detailed description

After screening, patients meeting all of the inclusion / non-inclusion criteria and vaccinated against meningococcal infections were divided into two subgroups according to the eculizumab treatment status (Soliris® naïve patients / patients who had received Soliris® at a maintenance dose prior to the trial inclusion). Each subgroup included an even number of patients to maintain recruitment balance. Then, patients of each subgroup were distributed into one of two treatment groups by the method of stratified block randomization at a 1:1 ratio into groups A and B, respectively. In the first group (Group A), patients received infusions of Elizaria (eculizumab, GENERIUM JSC), in the second one (Group B) - infusions of Soliris®. The duration of participation of each patient in the study, including the screening period, was about 30 weeks.

Conditions

• Paroxysmal Nocturnal Hemoglobinuria
• Marchiafava-Micheli Syndrome
• Paroxysmal Hemoglobinuria

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-11-29
• Primary completion: 2018-10-16
• Completion: 2018-10-16
• First posted: 2020-07-09
• Last updated: 2021-09-01

Locations

4 sites across 1 country: Russia