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

NCT05492409 | Completed Phase 3

• 1 other identifier: RMP-ITP-III-X
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 13

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

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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.

  up to 29 weeks

• 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.

  up to 29 weeks

• Number of clinically significant bleeding on Visits 1-5

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

  up to 29 weeks

• Number and proportion of the patient with antidrug antibodies.

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

  up to 29 weeks

Secondary Outcomes (3)

• Frequency of the loss of the treatment response

  up to 27 weeks

• Platelet count dynamics at Visits 1-5

  up to 5 weeks

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

  up to 27 weeks

Study Arms (1)

GNR-069

EXPERIMENTAL

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

Biological: GNR-069

Interventions

GNR-069 BIOLOGICAL

Once a week as a subcutaneous injection.

Also known as: romiplostim

GNR-069

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• AO GENERIUM: lead

Study Sites (13)

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

Ufa, Bashkortostan Republic, 450008, Russia

Location

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

Irkutsk, Irkutsk Oblast, 664079, Russia

Location

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

Kaluga, Kaluga Oblast, 248007, Russia

Location

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 Oblast, 603126, Russia

Location

Llc "Medis"

Nizhny Novgorod, Nizhny Novgorod Oblast, 603137, Russia

Location

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

Novosibirsk, Novosibirsk Oblast, 630091, Russia

Location

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 Oblast, 344022, Russia

Location

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

Tula, Tula Oblast, 300053, Russia

Location

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, Russia

Location

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

Moscow, 125167, Russia

Location

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, Russia

Location

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, Russia

Location

Municipal budgetary institution "Central City Hospital No. 7"

Yekaterinburg, 620137, Russia

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia; Hemorrhage; Purpura; Ecchymosis

Interventions

romiplostim

Condition Hierarchy (Ancestors)

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

Study Officials

• Oksana A. Markova, MD, MSc

  AO GENERIUM

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 8, 2022
• Study Start: March 28, 2022
• Primary Completion: April 3, 2024
• Study Completion: April 3, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (13)