A Safety and Immunogenicity Study in Long-term Treatment of Eculizumab (JSC "GENERIUM", Russian Federation) (NAP)
Paroxysmal Nocturnal Hemoglobinuria
About this trial
This is an interventional treatment trial for Paroxysmal Nocturnal Hemoglobinuria focused on measuring eculizumab, humanized monoclonal antibodies, safety, paroxysmal nocturnal hemoglobinuria, rare disease, biosimilar, complement system, C5 component of complement, pro-inflammatory cytokines, Membrane attack complex (MAC), immunogenicity
Eligibility Criteria
Inclusion Criteria:
Completion of participation in previous studies of Eculizumab (JSC "GENERIUM") while maintaining the clinical efficacy of the therapy with eculizumab.
In case of significant deviations from the protocol during participation in previous studies, the decision on the possibility of patient participation in this study is made on an individual basis in agreement with the company Sponsor.
- Written informed consent to participate in this study.
- Documented vaccination against meningococcal infection (serotypes A, C, Y and W135 Neisseria meningitides) with an unexpired period of validity and consent of the patient to undergo booster vaccination against meningococcal infection (serotypes A, C, Y and W135 Neisseria meningitides) while participating in this research when the previous vaccination expires.
- Consent to use a reliable method of contraception (a combination of at least 2 methods, including 1 barrier method, for example, using a condom and spermicide), from the moment of signing the informed consent until 10 weeks after the last administration of the study drug.
Exclusion Criteria:
- Hypersensitivity to the study drug, as well as to its components.
- Hypersensitivity to the active ingredients or any other component of the vaccine for the prevention of meningococcal infection, or a life-threatening reaction to the previous administration of a vaccine containing similar components.
- Comorbidities and conditions that, in the opinion of the Investigator, endanger the safety of the patient while participating in the study.
- Pregnancy or breastfeeding.
- Alcohol, drug or drug addiction.
Sites / Locations
- State budgetary healthcare institution "Chelyabinsk Regional Clinical Hospital"
- Federal State Budgetary Institution of Science "Kirov Research Institute of Hematology and Blood Transfusion of the Federal Medical and Biological Agency"
- Federal State Budgetary Educational Institution of Higher Education "First St. Petersburg State Medical University named after Academician I.P. Pavlov"
- Federal State Budgetary Institution "National Medical Research Center of Hematology" of the Ministry of Health of the Russian Federation
- State Budgetary Institution of Healthcare of the City of Moscow City Clinical Hospital named after S.P. Botkin of the Moscow Department of Health
- State budgetary institution of health care of the Moscow region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky"
- State budgetary institution of the Rostov region "Rostov Regional Clinical Hospital"
- Federal State Budgetary Educational Institution of Higher Education "Samara State Medical University" of the Ministry of Health of the Russian Federation
- State Budgetary Healthcare Institution of the Sverdlovsk Region "Sverdlovsk Regional Clinical Hospital No. 1"
Arms of the Study
Arm 1
Experimental
Eculisumab (JSC GENERIUM, Russia)
Eculizumab