Elena V. Gapchenko

RESULTS OF OPEN, PROSPECTIVE, MULTICENTER, NON-COMPARATIVE STUDY OF NONACOG ALPHA PHARMACOKINETICS, EFFICACY AND SAFETY IN CHILDREN AGED 2–12 YEARS WITH SEVERE AND MODERATE HEMOPHILIA В

T. A. Andreeva, Vladimir V. Lebedev, Vladimír Vdovin, Margarita Arkadevna Timofeeva et autres

The aim of the study was to evaluate the efficacy, safety and pharmacokinetics of nonacog alfa (Innonafactor) in children aged 2 to 12 years with hemophilia B. Materials and methods: 15 patients (7.7±2.5 years ) were included in an open, multicenter, prospective, …

Comparison of biosimilar Tigerase and Pulmozyme in long-term symptomatic therapy of patients with cystic fibrosis and severe pulmonary impairment (subgroup analysis of a Phase III randomized open-label clinical trial (NCT04468100))

E. Amelina, Stanislav Aleksandrovich Krasovsky, Nina E. Akhtyamova-Givirovskaya, Nataliya Y. Kashirskaya et autres

BACKGROUND: Patients with cystic fibrosis (CF) need costly medical care and adequate therapy with expensive medicinal products. Tigerase® is the first biosimilar of dornase alfa, developed by the lead Russian biotechnology company GENERIUM. The aim of the manuscript to present post hoc …

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EFFICACY AND SAFETY OF MOROCTOCOG ALFA IN AN OPEN, MULTICENTER, PROSPECTIVE, CLINICAL STUDY IN CHILDREN 2 TO 6 YEARS OF AGE WITH SEVERE HEMOPHILIA A

Margarita Arkadevna Timofeeva, Vladimir V. Lebedev, O. I. Plaksina, N. I. Zozulya et autres

The purpose of the study was to assess the efficacy, safety and pharmacokinetics of the moroctocog alfa (Octofactor) in children aged 2-6 with haemophilia A. Materials and methods of research : six patients between 2 and 6 years of age (average age …

SPECIFICITY OF THE MOROCTOCOG ALPHA MOLECULE: RESULTS OF A PROSPECTIVE, MULTICENTER, OPEN-LABEL, OBSERVATIONAL STUDY OF EFFICACY AND SAFETY IN CHILDREN AGED 12 TO 18 YEARS WITH HEMOPHILIA A

Vladimír Vdovin, Marina V. Kosinova, Margarita Arkadevna Timofeeva, G.N. Mustafina et autres

The main method of treatment for hemophilia A is replacement therapy with drugs of blood coagulation factors VIII (FVIII). The active use of biotechnological methods in the production of recombinant drugs contributes to the development and registration of new FVIII drugs. The …

Randomized multicenter noninferiority phase III clinical trial of the first biosimilar of eculizumab

Alexander Kulagin, Vadim V. Ptushkin, Elena Lukina, Alexander V. Korobkin et autres

Currently, eculizumab is the main effective treatment for paroxysmal nocturnal hemoglobinuria (PNH). The aim of this randomized multicenter noninferiority study was to evaluate the efficacy and safety of the Biosimilar (Elizaria) in comparison with the Originator (Soliris) in patients with PNH. Biosimilar …

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RESULTS OF THE OPEN MULTICENTER PROSPECTIVE CLINICAL STUDY OF THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF MOROCTOCOG ALPHA IN 6 TO 12 YEAR OLD CHILDREN WITH HEMOPHILIA A

Margarita Arkadevna Timofeeva, T. A. Andreeva, Vladimír Vdovin, Mamaev An et autres

Currently, the main method of treatment for hemophilia A is replacement therapy with drugs of blood coagulation factors VIII (FVIII). As a result of the development of new production technologies, recombinant FVIII are increasingly used for the treatment of hemophilia A. The …

RESULTS OF AN OPEN, PROSPECTIVE, MULTICENTER, NONCOMPARATIVE STUDY OF THE PHARMACOKINETICS, EFFICACY AND SAFETY OF NONACOG ALFA IN PATIENTS AGED 6–12 YEARS WITH SEVERE AND MODERATE HEMOPHILIA B

T. A. Andreeva, Vladimir V. Lebedev, Vladimír Vdovin, Margarita Arkadevna Timofeeva et autres

Providing hemophilia patients with blood coagulation preparations is one of the priority tasks of the national health care system. In 2011, the first recombinant factor IX was created in Russia (rFIX, nonacog alpha, Innonafactor, GENERIUM JSC), that was previously studied for pharmacokinetic …

Results of phase Ib open multicenter clinical trial of the safety, pharmacokinetics and pharmacodynamics of first biosimilar of eculizumab in untreated patients with paroxysmal nocturnal hemoglobinuria during induction of therapy

Vadim V. Ptushkin, Alexander Kulagin, Elena Lukina, Tatiana S. Konstantinova et autres

Currently, the main pathogenetic method for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) is the treatment with recombinant monoclonal antibodies that block the C5 component of the complement system. Eculizumab is the first biotechnological drug, which is a monoclonal antibody, with proven …

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Evaluation of the efficacy and safety of the biosimilar drug Glurazyme (imiglucerase) in patients with Gaucher disease type 1

Elena P. Sysoeva, Rodion V. Ponomarev, K. A. Lukina, R. B. Chavynchak et autres

Background. Gaucher disease (GD) is a rare hereditary condition, which represents the most common form of lysosomal storage diseases. Enzyme replacement therapy (ERT) with recombinant glucocerebrosidase is used for the treatment of type 1 and type 3 GD. Imiglucerase (recombinant glucocerebrosidase) is …

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Results of a phase I open randomized comparative crossover clinical trial to assess the safety and pharmacokinetics of Glurazyme® (imiglucerase) in comparison with the reference product in healthy volunteers

Sergey B. Fitilev, Alexander V. Vozzhaev, И. И. Шкребнева, Dmitry Anatolievich Kudlay et autres

Background. Currently, the main treatment for Gaucher disease is enzyme replacement therapy. Recombinant glucocerebrosidase (imiglu-cerase) is the first biotechnological drug for enzyme replacement therapy with proven clinical efficacy and safety for the treatment of patients of different ages with Gaucher disease type …

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Phase III Clinical Trial of Elizaria® and Soliris® in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria: Results of Comparative Analysis of Efficacy, Safety, and Pharmacological Data

Alexander Kulagin, Vadim V. Ptushkin, Elena Lukina, Elena V. Gapchenko et autres

Introduction: Complement C5-inhibitor eculizumab is a current standard of care in patients with paroxysmal nocturnal hemoglobinuria (PNH). Elizaria® is the first registered biosimilar of the reference medicinal product Soliris®. Purpose: To demonstrate Elizaria® comparative efficacy and safety vs. reference product Soliris® in …

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INTER-DIAGNOSTIC APPROACHES IN POST-ADVOCACY SCIENCE: POSSIBILITIES OF SELF-REFLECTION IN POLITICAL DISCOURSE

Volodymyr Mykhailovych Gotsulyak, Andrey E. Levchenko, Elena V. Gapchenko

Modern post-classical science is experiencing a time of rapid development, that is enriching its methodological potential by developing interdisciplinary approaches and outlining new areas of research, the subject of which are complex human-dimensional systems.Interdisciplinary opens up new perspectives for understanding the Ukrainian …

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