Study of Efficacy, Safety and Immunogenicity of GP40141 (GEROPHARM, Russia) in Patients With Immune Thrombocytopenia

Summary

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.

Timeline

Start

2023-04-04

Primary completion

2028-03-31

Completion

2028-03-31

Publications

• Melikyan AL, Protsenko EA, Salogub GN, Bakirov BA, Davydkin IL, Kovalik VV, Gefen ML, Matvienko YD, Saparova VB, Khokhlov AL, Makarenko IE, Drai RV. Multicenter Single-Blind Randomized Controlled Trial of the Romiplostim Biosimilar. EJHaem. 2025 Jul 24;6(4):e70105. doi: 10.1002/jha2.70105. eCollection 2025 Aug.

Drugs

Indications

No indication recorded.