Study of the Safety and Immunogenicity of Long-term GNR-069 Therapy in ITP Patients
Idiopathic Thrombocytopenic Purpura
About this trial
This is an interventional treatment trial for Idiopathic Thrombocytopenic Purpura focused on measuring Idiopathic thrombocytopenic purpura, ITP, Thrombocytopenia, Thrombocytopoiesis, Bleeding, Hemorrhagic syndrome, Petechial rash, Ecchymosis, Fc-peptide, Recombinant DNA technology, Thrombopoietin receptors, Platelet formation, Fc fragment of human immunoglobulin IgG 1, Low platelet count, ITP treatment, Platelets, Haemorrhage, Platelet destruction, Impaired thrombopoiesis, Megakaryocytes, Autoantibodies, Splenectomy, Cytotoxic, T cells, Thrombopoietin receptor agonists, Thrombopoietin receptor mimetic, TPO-RAs, romiplostim, Nplate
Eligibility Criteria
Inclusion Criteria:
- Completion of participation in the study RMP-ITP-III while maintaining the clinical effectiveness of romiplostim therapy
Exclusion Criteria:
- Hypersensitivity to the components of the study drug or E. Coli proteins;
- Pregnancy or breastfeeding;
- Any diseases and conditions that, in the opinion of the Investigator, may hinder the patient's participation in the study
Sites / Locations
- State Budgetary Institution of Healthcare Irkutsk awarded the "Sign of Honor" Order Regional Clinical Hospital
- State Budgetary Health Institution of the Kaluga Region "Kaluga Regional Clinical Hospital"
- State budgetary institution of health care of the Nizhny Novgorod region "Nizhny Novgorod Regional Clinical Hospital named after N. A. Semashko"
- Llc "Medis"
- Federal State Budgetary Educational Institution of Higher Education "Novosibirsk State Medical University" of the Ministry of Health of the Russian Federation
- Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation
- Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University" of the Ministry of Health of the Russian Federation
- State Health Institution of the Tula Region "Tula Regional Clinical Hospital"
- Municipal budgetary institution "Central City Hospital No. 7"
- State Budgetary Institution of Healthcare of the city of Moscow "Moscow Clinical Scientific and Practical Center named after A.S. Loginov" Department of Health of the city of Moscow
- Federal State Budget Funded Institution National Medical Research Center of Hematology, Ministry of Health of the Russian Federation (MoH of Russia)
- State budgetary health care institution of the city of Moscow "City Clinical Hospital named after V.V. Veresaev of the Department of Health of the City of Moscow"
- Federal State Budgetary Institution "National Medical Research Center named after V.A. Almazov" of the Ministry of Health of the Russian Federation
Arms of the Study
Arm 1
Experimental
GNR-069
Weekly subcutaneous injections of GNR-069 in the individually titrated dose.