Overview

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

Status:
ACTIVE_NOT_RECRUITING

Trial end date:
2028-03-31

Target enrollment:

Participant gender:

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.

Phase:

PHASE3

Details

Lead Sponsor:

Geropharm

Collaborators:

I.M. Sechenov First Moscow State Medical University
Pharm-Holding

Treatments:

romiplostim