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

PHASE3CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

April 4, 2019

Primary Completion Date

April 27, 2020

Study Completion Date

December 30, 2020

Conditions
Paroxysmal Nocturnal Hemoglobinuria
Interventions
BIOLOGICAL

BCD-148

"Active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5.~Cycle 1 (induction therapy): 600 mg of eculizumab QW for the first four weeks; Cycle 2 (maintenance therapy): 900 mg of eculizumab at Week 5 and 900 mg of eculizumab every 14±2 days until Week 27 (inclusive) afterwards (dosing regimen for the main study period).~QW - once weekly"

BIOLOGICAL

Soliris

"Active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5.~Cycle 1 (induction therapy): 600 mg of eculizumab QW for the first four weeks; Cycle 2 (maintenance therapy): 900 mg of eculizumab at Week 5 and 900 mg of eculizumab every 14±2 days until Week 27 (inclusive) afterwards (dosing regimen for the main study period)."

Trial Locations (1)

Unknown

"Federal State Budgetary Educational Institution of Higher Education Academician I.P. Pavlov First St. Petersburg State Medical University of the Ministry of Healthcare of Russian Federation", Saint Petersburg

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biocad

INDUSTRY