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

Primary Purpose

Idiopathic Thrombocytopenic Purpura

Status
Enrolling by invitation
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
GNR-069
Sponsored by
AO GENERIUM
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Thrombocytopenic Purpura focused on measuring Idiopathic thrombocytopenic purpura, ITP, Thrombocytopenia, Thrombocytopoiesis, Bleeding, Hemorrhagic syndrome, Petechial rash, Ecchymosis, Fc-peptide, Recombinant DNA technology, Thrombopoietin receptors, Platelet formation, Fc fragment of human immunoglobulin IgG 1, Low platelet count, ITP treatment, Platelets, Haemorrhage, Platelet destruction, Impaired thrombopoiesis, Megakaryocytes, Autoantibodies, Splenectomy, Cytotoxic, T cells, Thrombopoietin receptor agonists, Thrombopoietin receptor mimetic, TPO-RAs, romiplostim, Nplate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • State Budgetary Institution of Healthcare Irkutsk awarded the "Sign of Honor" Order Regional Clinical Hospital
  • State Budgetary Health Institution of the Kaluga Region "Kaluga Regional Clinical Hospital"
  • State budgetary institution of health care of the Nizhny Novgorod region "Nizhny Novgorod Regional Clinical Hospital named after N. A. Semashko"
  • Llc "Medis"
  • Federal State Budgetary Educational Institution of Higher Education "Novosibirsk State Medical University" of the Ministry of Health of the Russian Federation
  • Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation
  • Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University" of the Ministry of Health of the Russian Federation
  • State Health Institution of the Tula Region "Tula Regional Clinical Hospital"
  • Municipal budgetary institution "Central City Hospital No. 7"
  • 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
  • Federal State Budget Funded Institution National Medical Research Center of Hematology, Ministry of Health of the Russian Federation (MoH of Russia)
  • 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"
  • Federal State Budgetary Institution "National Medical Research Center named after V.A. Almazov" of the Ministry of Health of the Russian Federation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GNR-069

Arm Description

Weekly subcutaneous injections of GNR-069 in the individually titrated dose.

Outcomes

Primary Outcome Measures

Frequency and severity of adverse events associated with the use of the GNR-069
Adverse events will be assessed based on complaints, physical examination and laboratory data.
Number of undesirable events of particular interest in the study (Bleeding;Thrombotic/thromboembolic events)
The event of particular interest in this study are bleeding and thrombotic/thromboembolic events of any location.
Number of clinically significant bleeding on Visits 1-5
The clinically significant bleeding will be considered events ≥ grade 2 according to CTCAE 5.0.
Number and proportion of the patient with antidrug antibodies.
The antidrug antibodies willl be characterized by their type, titer and neutralizing activity.

Secondary Outcome Measures

Frequency of the loss of the treatment response
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.
Platelet count dynamics at Visits 1-5
The platalets must be counted till week 5
Сhange in ITP-BAT bleeding scores from baseline to week 27
ITP-specific bleeding assessment tool (ITP-BAT) will be calculated at baseline and at week 27.

Full Information

First Posted
August 3, 2022
Last Updated
February 27, 2023
Sponsor
AO GENERIUM
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1. Study Identification

Unique Protocol Identification Number
NCT05492409
Brief Title
Study of the Safety and Immunogenicity of Long-term GNR-069 Therapy in ITP Patients
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
November 20, 2023 (Anticipated)
Study Completion Date
January 16, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AO GENERIUM

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Thrombocytopenic Purpura
Keywords
Idiopathic thrombocytopenic purpura, ITP, Thrombocytopenia, Thrombocytopoiesis, Bleeding, Hemorrhagic syndrome, Petechial rash, Ecchymosis, Fc-peptide, Recombinant DNA technology, Thrombopoietin receptors, Platelet formation, Fc fragment of human immunoglobulin IgG 1, Low platelet count, ITP treatment, Platelets, Haemorrhage, Platelet destruction, Impaired thrombopoiesis, Megakaryocytes, Autoantibodies, Splenectomy, Cytotoxic, T cells, Thrombopoietin receptor agonists, Thrombopoietin receptor mimetic, TPO-RAs, romiplostim, Nplate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GNR-069
Arm Type
Experimental
Arm Description
Weekly subcutaneous injections of GNR-069 in the individually titrated dose.
Intervention Type
Biological
Intervention Name(s)
GNR-069
Other Intervention Name(s)
romiplostim
Intervention Description
Once a week as a subcutaneous injection.
Primary Outcome Measure Information:
Title
Frequency and severity of adverse events associated with the use of the GNR-069
Description
Adverse events will be assessed based on complaints, physical examination and laboratory data.
Time Frame
up to 29 weeks
Title
Number of undesirable events of particular interest in the study (Bleeding;Thrombotic/thromboembolic events)
Description
The event of particular interest in this study are bleeding and thrombotic/thromboembolic events of any location.
Time Frame
up to 29 weeks
Title
Number of clinically significant bleeding on Visits 1-5
Description
The clinically significant bleeding will be considered events ≥ grade 2 according to CTCAE 5.0.
Time Frame
up to 29 weeks
Title
Number and proportion of the patient with antidrug antibodies.
Description
The antidrug antibodies willl be characterized by their type, titer and neutralizing activity.
Time Frame
up to 29 weeks
Secondary Outcome Measure Information:
Title
Frequency of the loss of the treatment response
Description
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.
Time Frame
up to 27 weeks
Title
Platelet count dynamics at Visits 1-5
Description
The platalets must be counted till week 5
Time Frame
up to 5 weeks
Title
Сhange in ITP-BAT bleeding scores from baseline to week 27
Description
ITP-specific bleeding assessment tool (ITP-BAT) will be calculated at baseline and at week 27.
Time Frame
up to 27 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oksana A. Markova, MD, MSc
Organizational Affiliation
AO GENERIUM
Official's Role
Study Chair
Facility Information:
Facility Name
State Budgetary Institution of Healthcare Irkutsk awarded the "Sign of Honor" Order Regional Clinical Hospital
City
Irkutsk
State/Province
Irkutsk Region
ZIP/Postal Code
664079
Country
Russian Federation
Facility Name
State Budgetary Health Institution of the Kaluga Region "Kaluga Regional Clinical Hospital"
City
Kaluga
State/Province
Kaluga Region
ZIP/Postal Code
248007
Country
Russian Federation
Facility Name
State budgetary institution of health care of the Nizhny Novgorod region "Nizhny Novgorod Regional Clinical Hospital named after N. A. Semashko"
City
Nizhny Novgorod
State/Province
Nizhny Novgorod Region
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Llc "Medis"
City
Nizhny Novgorod
State/Province
Nizhny Novgorod Region
ZIP/Postal Code
603137
Country
Russian Federation
Facility Name
Federal State Budgetary Educational Institution of Higher Education "Novosibirsk State Medical University" of the Ministry of Health of the Russian Federation
City
Novosibirsk
State/Province
Novosibirsk Region
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation
City
Ufa
State/Province
Republic Of Bashkortostan
ZIP/Postal Code
450008
Country
Russian Federation
Facility Name
Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University" of the Ministry of Health of the Russian Federation
City
Rostov-on-Don
State/Province
Rostov Region
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
State Health Institution of the Tula Region "Tula Regional Clinical Hospital"
City
Tula
State/Province
Tula Region
ZIP/Postal Code
300053
Country
Russian Federation
Facility Name
Municipal budgetary institution "Central City Hospital No. 7"
City
Ekaterinburg
ZIP/Postal Code
620137
Country
Russian Federation
Facility Name
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
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
Federal State Budget Funded Institution National Medical Research Center of Hematology, Ministry of Health of the Russian Federation (MoH of Russia)
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
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"
City
Moscow
ZIP/Postal Code
127644
Country
Russian Federation
Facility Name
Federal State Budgetary Institution "National Medical Research Center named after V.A. Almazov" of the Ministry of Health of the Russian Federation
City
Saint Petersburg
ZIP/Postal Code
191014
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

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

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