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GENERIUM, AO

🇷🇺Russia
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Study of the Safety and Immunogenicity of Long-term GNR-069 Therapy in ITP Patients

Phase 3
Completed
Conditions
Idiopathic Thrombocytopenic Purpura
Interventions
Biological: GNR-069
First Posted Date
2022-08-08
Last Posted Date
2024-06-21
Lead Sponsor
AO GENERIUM
Target Recruit Count
160
Registration Number
NCT05492409
Locations
🇷🇺

State Budgetary Institution of Healthcare Irkutsk awarded the "Sign of Honor" Order Regional Clinical Hospital, Irkutsk, Irkutsk Region, Russian Federation

🇷🇺

State Budgetary Health Institution of the Kaluga Region "Kaluga Regional Clinical Hospital", Kaluga, Kaluga Region, Russian Federation

🇷🇺

State budgetary institution of health care of the Nizhny Novgorod region "Nizhny Novgorod Regional Clinical Hospital named after N. A. Semashko", Nizhny Novgorod, Nizhny Novgorod Region, Russian Federation

and more 10 locations

Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With ITP

Phase 3
Completed
Conditions
Idiopathic Thrombocytopenic Purpura
Interventions
Biological: Nplate
Biological: GNR-069
First Posted Date
2022-02-02
Last Posted Date
2024-03-06
Lead Sponsor
AO GENERIUM
Target Recruit Count
160
Registration Number
NCT05220878
Locations
🇷🇺

State Budgetary Institution of Healthcare Irkutsk awarded the "Sign of Honor" Order Regional Clinical Hospital, Irkutsk, Irkutsk Region, Russian Federation

🇷🇺

State Budgetary Health Institution of the Kaluga Region "Kaluga Regional Clinical Hospital", Kaluga, Kaluga Region, Russian Federation

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State Autonomous Healthcare Institution "Kuzbass Clinical Hospital named after S.V. Belyaev", Kemerovo, Kemerovo Region, Russian Federation

and more 15 locations

A Multi-cohort Study of Safety, Efficacy, PK and PD of GNR-055 in Patients With Mucopolysaccharidosis Type II

Phase 2
Recruiting
Conditions
Mucopolysaccharidosis Type II
Metabolic Diseases
Interventions
Drug: GNR-055 1.0-2.0-3.0 mg/kg
Drug: GNR-055 2.0 mg/kg
Drug: GNR-055 3.0 mg/kg
First Posted Date
2022-01-26
Last Posted Date
2024-03-06
Lead Sponsor
AO GENERIUM
Target Recruit Count
32
Registration Number
NCT05208281
Locations
🇷🇺

State Autonomous Healthcare Institution of the Sverdlovsk Region Regional Children's Clinical Hospital, Ekaterinburg, Russian Federation

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Federal State-Funded Healthcare Institution Central Clinical Hospital of the Russian Academy of Sciences (Research Institute of Pediatrics and Child Health Protection of the Central Clinical Hospital of the Russian Academy of Sciences), Moscow, Russian Federation

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V.I. Vernadsky Crimean Federal University, Simferopol, Russian Federation

and more 2 locations

Efficacy and Safety of GNR-038 vs Berinert® in Patients With Hereditary Angioedema

Phase 2
Withdrawn
Conditions
Hereditary Angioedema
Interventions
Drug: GNR-038, 50 МЕ/ kg
Drug: GNR-038. The dose will be selected according to results of stage 1 clinical trial.
Drug: Placebo
Drug: Berinert®, 20 МЕ/ kg
Drug: GNR-038, 100 МЕ/ kg
First Posted Date
2021-05-24
Last Posted Date
2022-02-04
Lead Sponsor
AO GENERIUM
Registration Number
NCT04898309
Locations
🇷🇺

National Research Center - Institute of Immunology Federal Medical-Biological Agency of Russia, Moscow, Russian Federation

🇷🇺

Moscow City Clinical Hospital 52, Moscow, Russian Federation

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Federal State Budgetary Scientific Institution Research Institute of Fundamental and Clinical Immunology, Moscow, Russian Federation

and more 2 locations

Observational Study of Elizaria® in aHUS Patients

Completed
Conditions
aHUS
Atypical Hemolytic Uremic Syndrome
Interventions
Drug: Elizaria®
First Posted Date
2021-02-11
Last Posted Date
2022-08-04
Lead Sponsor
AO GENERIUM
Target Recruit Count
50
Registration Number
NCT04749810
Locations
🇷🇺

Federal State Budgetary Educational Institution of Higher Education "Kazan State Medical University" of the Ministry of Health of the Russian Federation, Kazan, Russian Federation

🇷🇺

Regional State Budgetary Healthcare Institution "Krasnoyarsk' Regional Clinical Center for Maternity and Childhood Protection", Krasnoyarsk, Russian Federation

🇷🇺

State budgetary healthcare institution of the city of Moscow "Children's City Clinical Hospital of St. Vladimir of the Healthcare Department of the City of Moscow", Moscow, Russian Federation

and more 5 locations

A Safety and Immunogenicity Study in Long-term Treatment of Eculizumab (JSC "GENERIUM", Russian Federation)

Phase 3
Completed
Conditions
Paroxysmal Nocturnal Hemoglobinuria
Interventions
Biological: Eculizumab (JSC GENERIUM, Russia)
First Posted Date
2020-12-22
Last Posted Date
2020-12-28
Lead Sponsor
AO GENERIUM
Target Recruit Count
50
Registration Number
NCT04679103
Locations
🇷🇺

State budgetary healthcare institution "Chelyabinsk Regional Clinical Hospital", Chelyabinsk, Chelyabinsk Region, Russian Federation

🇷🇺

Federal State Budgetary Institution of Science "Kirov Research Institute of Hematology and Blood Transfusion of the Federal Medical and Biological Agency", Kirov, Kirov Region, Russian Federation

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Federal State Budgetary Educational Institution of Higher Education "First St. Petersburg State Medical University named after Academician I.P. Pavlov", Saint Petersburg, Leningrad Region, Russian Federation

and more 6 locations

Prospective Observational Study of Long-term Pathogenic Treatment of Elizaria®

Completed
Conditions
Paroxysmal Nocturnal Hemoglobinuria
First Posted Date
2020-12-17
Last Posted Date
2023-09-13
Lead Sponsor
AO GENERIUM
Target Recruit Count
44
Registration Number
NCT04671810
Locations
🇷🇺

State budgetary healthcare institution "Chelyabinsk Regional Clinical Hospital", Chelyabinsk, Chelyabinsk Region, Russian Federation

🇷🇺

State Budgetary Institution of Healthcare Irkutsk Order of the "Badge of Honor" Regional Clinical Hospital, Irkutsk, Irkutsk Region, 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, Moscow, Moscow Region, Russian Federation

and more 5 locations

Efficacy, Safety, pharmacokinetiсs, Immunogenicity of GNR-067 and Lucentis®

Phase 3
Recruiting
Conditions
Age Related Macular Degeneration (ARMD)
Interventions
Biological: GNR-067
Biological: Lucentis®
First Posted Date
2020-12-14
Last Posted Date
2023-09-13
Lead Sponsor
AO GENERIUM
Target Recruit Count
408
Registration Number
NCT04667039
Locations
🇷🇺

Regional budgetary healthcare institution "Ivanovo Regional Clinical Hospital", Ivanovo, Ivanovo Region, Russian Federation

🇷🇺

State Budgetary Healthcare Facility of the St. Petersburg Region "First St. Petersburg State Medical University named after academician I.P. Pavlova "of the Ministry of Health of the Russian Federation, Saint Petersburg, Leningrad Region, Russian Federation

🇷🇺

Federal State Budgetary Educational Institution of Higher Education "Moscow State University of Medicine and Dentistry named after A.I. Evdokimov "of the Ministry of Health of the Russian Federation, Moscow, Moscow Region, Russian Federation

and more 6 locations

An Efficacy and Safety Study of Genolar® and Xolar® in the Persistent Atopic Bronchial Asthma

Phase 3
Completed
Conditions
Bronchial Asthma
Interventions
Biological: Genolar® + Symbicort®
Biological: Xolair® + Symbicort®
First Posted Date
2020-10-29
Last Posted Date
2020-10-29
Lead Sponsor
AO GENERIUM
Target Recruit Count
192
Registration Number
NCT04607629
Locations
🇷🇺

Limited Liability Company "MDP-Medical Group", Odintsovo, Moscow Region, Russian Federation

🇷🇺

State Budgetary Healthcare Institution of the Perm Territory "Clinical Medical and Sanitary Unit No. 1, Perm, Perm Territory, Russian Federation

🇷🇺

State Budgetary Healthcare Institution "Republican Clinical Hospital named after G.G. Kuvatov", Ufa, Republic Of Bashkortostan, Russian Federation

and more 21 locations

GNR-084 Safety and Pharmacological Characteristics in Refractory or Relapse B-cell Precursor ALL

Phase 1
Recruiting
Conditions
ALL
GNR-084
B-precursor Acute Lymphoblastic Leukemia
Interventions
Biological: Cohort 1, GNR-084
Biological: Cohort 2, GNR-084
Biological: Cohort 5, GNR-084
Biological: Cohort 6, GNR-084
Biological: Cohort 3, GNR-084
Biological: Cohort 4, GNR-084
First Posted Date
2020-10-26
Last Posted Date
2024-03-06
Lead Sponsor
AO GENERIUM
Target Recruit Count
36
Registration Number
NCT04601584
Locations
🇷🇺

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

🇷🇺

Almazov National Medical Research Centre, Saint Petersburg, Russian Federation

🇷🇺

Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russian Federation

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