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

Exclusion Criteria

• •1. Hypersensitivity to the components of investigational or reference drug or E. coli proteins ;
• •2. Unresolved severe hemorrhagic syndrome requiring emergency treatment at the time of initiation of study or reference drug therapy ;
• •3. Fisher-Evans Syndrome;
• •4. Conditions with a high risk of thromboembolic complications ;
• •5. Myelodysplastic syndrome and/or bone marrow transplantation in anamnesis;
• •6. Deviations of clinical and laboratory parameters according to the results of studies of blood samples taken during the screening period;
• •7. Positive test results for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV);
• •8. Pregnancy or breastfeeding;
• •9. Use of drugs:
• •* romiplostim used less than 3 weeks before treatment with study or reference drug;
• •* IVIG - less than 2 weeks prior to initiation of study or reference drug therapy;
• •* eltrombopag - used less than 2 weeks before treatment with study or reference drug, or planned to use eltrombopag while the patient is participating in this study;
• •* rituximab - used less than 14 weeks before treatment with study or reference drug, or planned to use rituximab while the patient is enrolled in this study;
• •* cyclophosphamide, cyclosporine, vincristine, vinblastine and other drugs used to treat ITP not listed above and not included in the list of drugs approved for use during the study - use less than 8 weeks before the start of therapy with the study or reference drug or the use of any of these drugs is planned during the patient's participation in this study;
• •* preparations of any hematopoietic growth factors - use less than 8 weeks before the start of therapy with an investigational or reference drug;
• •* Influenza vaccines - less than 21 days prior to start of treatment with study or reference drug;
• •* vaccines to prevent novel coronavirus disease (COVID-19) - completion of the vaccination program less than 21 days prior to the start of study or reference drug therapy;
• •* other vaccines - less than 8 weeks prior to start of treatment with study or reference drug;
• •10. Splenectomy within 12 weeks prior to screening;
• •11. Participation in any clinical trials and/or use of unregistered drugs within 4 weeks prior to screening or 5 drug half-lives (whichever is greater);
• •12. Any other disease or condition that, in the opinion of the investigator, may preclude the patient from participating in the study.