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

NCT06497036 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-07-11

No results posted yet for this study

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.

Conditions

  • Drug Effect
  • Safety Issues
  • Immunogenicity

Interventions

DRUG

GP404141

subcutaneous injection

DRUG

Nplate

subcutaneous injection

Sponsors & Collaborators

  • Pharm-Holding

    collaborator UNKNOWN

  • I.M. Sechenov First Moscow State Medical University

    collaborator OTHER

  • Geropharm

    lead INDUSTRY

Principal Investigators

  • Bulat Bakirov, MD · Bashkir State Medical University of the Ministry of Health of the Russian Federation

  • Elena Borisenkova · Kaluga Regional Clinical Hospital

  • Olga Vinogradova · City Clinical Hospital named after S.P. Botkin of the Moscow City Health Department

  • Igor Davydkin · Samara State Medical University of the Ministry of Health of the Russian Federation

  • Dmitry Kirtbaya · Oncological dispensary No. 2 of the Ministry of Health of the Krasnodar Territory

  • Galina Salogub · National Medical Research Center VA Almazov Ministry of Health of the Russian Federation

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-04
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06497036 on ClinicalTrials.gov