Study of the Safety and Immunogenicity of Long-term GNR-069 Therapy in ITP Patients

Last updated: June 20, 2024
Sponsor: AO GENERIUM
Overall Status: Completed

Phase

3

Condition

Thrombocytopenic

Immune Thrombocytopenia (Itp)

Immune (Idiopathic) Thrombocytopenic Purpura (Itp)

Treatment

GNR-069

Clinical Study ID

NCT05492409
RMP-ITP-III-X
  • Ages 18-75
  • All Genders

Study Summary

It is a phase III extension study to assess safety and immunogenicity of long-term therapy with GNR-069 in patients with idiopathic thrombocytopenic purpura

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Completion of participation in the study RMP-ITP-III while maintaining the clinicaleffectiveness of romiplostim therapy

Exclusion

Exclusion Criteria:

  • Hypersensitivity to the components of the study drug or E. Coli proteins;

  • Pregnancy or breastfeeding;

  • Any diseases and conditions that, in the opinion of the Investigator, may hinder thepatient's participation in the study

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: GNR-069
Phase: 3
Study Start date:
March 28, 2022
Estimated Completion Date:
April 03, 2024

Study Description

It is an extension study in patients with ITP who completed participation in RMP-ITP-III clinical trial.

The study will be conducted in three stages:

  • Transition visit - 1 day (transition of clinical trial participants from the RMP-ITP-III study to the RMP-ITP-III-X study);

  • Treatment period - minimum 26 weeks;

  • Follow-up period - 1 week. Patients will then be provided with the study therapy till the product market access with only safety data collection.

Connect with a study center

  • State Budgetary Institution of Healthcare Irkutsk awarded the "Sign of Honor" Order Regional Clinical Hospital

    Irkutsk, Irkutsk Region 664079
    Russian Federation

    Site Not Available

  • State Budgetary Health Institution of the Kaluga Region "Kaluga Regional Clinical Hospital"

    Kaluga, Kaluga Region 248007
    Russian Federation

    Site Not Available

  • Llc "Medis"

    Nizhny Novgorod, Nizhny Novgorod Region 603137
    Russian Federation

    Site Not Available

  • State budgetary institution of health care of the Nizhny Novgorod region "Nizhny Novgorod Regional Clinical Hospital named after N. A. Semashko"

    Nizhny Novgorod, Nizhny Novgorod Region 603126
    Russian Federation

    Site Not Available

  • Federal State Budgetary Educational Institution of Higher Education "Novosibirsk State Medical University" of the Ministry of Health of the Russian Federation

    Novosibirsk, Novosibirsk Region 630091
    Russian Federation

    Site Not Available

  • Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation

    Ufa, Republic Of Bashkortostan 450008
    Russian Federation

    Site Not Available

  • Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University" of the Ministry of Health of the Russian Federation

    Rostov-on-Don, Rostov Region 344022
    Russian Federation

    Site Not Available

  • State Health Institution of the Tula Region "Tula Regional Clinical Hospital"

    Tula, Tula Region 300053
    Russian Federation

    Site Not Available

  • Municipal budgetary institution "Central City Hospital No. 7"

    Ekaterinburg, 620137
    Russian Federation

    Site Not Available

  • Federal State Budget Funded Institution National Medical Research Center of Hematology, Ministry of Health of the Russian Federation (MoH of Russia)

    Moscow, 125167
    Russian Federation

    Site Not Available

  • State Budgetary Institution of Healthcare of the city of Moscow "Moscow Clinical Scientific and Practical Center named after A.S. Loginov" Department of Health of the city of Moscow

    Moscow, 111123
    Russian Federation

    Site Not Available

  • State budgetary health care institution of the city of Moscow "City Clinical Hospital named after V.V. Veresaev of the Department of Health of the City of Moscow"

    Moscow, 127644
    Russian Federation

    Site Not Available

  • Federal State Budgetary Institution "National Medical Research Center named after V.A. Almazov" of the Ministry of Health of the Russian Federation

    Saint Petersburg, 191014
    Russian Federation

    Site Not Available

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