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ACTIVE NOT RECRUITING
NCT06497036
PHASE3

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

Sponsor: Geropharm

View on ClinicalTrials.gov

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.

Official title: Multicenter Randomized Controlled Study of Efficacy, Safety and Immunogenicity of GP40141 (GEROPHARM, Russia) Compared With Nplate® (Amgen, the Netherlands) in Patients With Persistent or Early Immune Thrombocytopenia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2023-04-04

Completion Date

2028-03-31

Last Updated

2024-07-11

Healthy Volunteers

No

Interventions

DRUG

GP404141

subcutaneous injection

DRUG

Nplate

subcutaneous injection

Locations (6)

Kaluga Regional Clinical Hospital

Kaluga, Russia

City Clinical Hospital S.P. Botkin of the Moscow City Health Department

Moscow, Russia

National Medical Research Center in name of V.A. Almazov " of the Ministry of Health of the Russian Federation

Saint Petersburg, Russia

Samara State Medical University" of the Ministry of Health of the Russian Federation

Samara, Russia

Oncological dispensary No. 2 of the Ministry of Health of the Krasnodar Territory

Sochi, Russia

Federal State Budgetary Educational Institution Bashkir State Medical University of the Ministry of Health of the Russian Federation

Ufa, Russia