Описание: | The goal of this clinical trial is to demonstrate equivalent efficacy and comparable safety of the drug GP40141 (GEROPHARM, Russia) in comparison with the drug Nplate® (Amgen, the Netherlands). the main questions are 1. Assess the effectiveness of GP40141 in comparison with Nplate®. 2. Assess the immunogenicity of GP40141 in comparison with the drug Nplate®. 3. Assess the safety of GP40141 in comparison with the drug Nplate®. 4. Assess the safety of changing romiplostim and eltrombopag to GP40141. 5. Assess the pharmacokinetic parameters of the study drugs in patients with primary immune thrombocytopenia. Participants divided into 2 cohorts (naïve or treated with a thrombopoietin receptor agonist) will receive romiplostim and platelet response, immune response and adverse reactions will be assessed. |