Бакиров Булат Ахатович


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GP40141-P4-03-02 ClinicalTrials.gov

Статус: Active, not recruiting
Фаза: Phase 3
Начало: 4 апреля 2023 г.
Окончание: 31 марта 2028 г.
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.
смотреть на ClinicalTrials.gov