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NCT Number: NCT05492409

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

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

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Key information

Conditions

Idiopathic Thrombocytopenic Purpura Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Ecchymosis Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation, Ufa, Bashkortostan Republic, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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 the patient's participation in the study

Treatment and study plan

GNR-069

Biological

Once a week as a subcutaneous injection.

Other names: romiplostim

Primary outcomes

  1. Frequency and severity of adverse events associated with the use of the GNR-069

    Time frame: up to 29 weeks

    Adverse events will be assessed based on complaints, physical examination and laboratory data.

  2. Number of undesirable events of particular interest in the study (Bleeding;Thrombotic/thromboembolic events)

    Time frame: up to 29 weeks

    The event of particular interest in this study are bleeding and thrombotic/thromboembolic events of any location.

  3. Number of clinically significant bleeding on Visits 1-5

    Time frame: up to 29 weeks

    The clinically significant bleeding will be considered events ≥ grade 2 according to CTCAE 5.0.

  4. Number and proportion of the patient with antidrug antibodies.

    Time frame: up to 29 weeks

    The antidrug antibodies willl be characterized by their type, titer and neutralizing activity.

Secondary outcomes

  1. Frequency of the loss of the treatment response

    Time frame: up to 27 weeks

    Loss of the treatment response is assessed as absense of platelet increase ≥ 50,0 х 109/L on the 4 weeks treatment with maximal study drug dose.

  2. Platelet count dynamics at Visits 1-5

    Time frame: up to 5 weeks

    The platalets must be counted till week 5

  3. Сhange in ITP-BAT bleeding scores from baseline to week 27

    Time frame: up to 27 weeks

    ITP-specific bleeding assessment tool (ITP-BAT) will be calculated at baseline and at week 27.

Sponsors and collaborators

Lead sponsor

AO GENERIUM

Industry

Registry information

Official study title

Extension Study of Long-term Safety and Immunogenicity of GNR-069 Patients With Idiopathic Thrombocytopenic Purpura Who Completed Phase 3 RMP-ITP-III Clinical Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 8, 2022
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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