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

Phase 3

Completed

• Conditions: Idiopathic Thrombocytopenic Purpura
• Interventions: Biological: GNR-069

• Registration Number: NCT05492409
• Lead Sponsor: AO GENERIUM

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.

Study Timeline

• Study Start: 2022-03-28
• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-05
• Study First Posted: 2022-08-08
• Status Verified: 2024-03
• Primary Completion: 2024-04-03
• Study Completion: 2024-04-03
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Frequency and severity of adverse events associated with the use of the GNR-069	up to 29 weeks	Adverse events will be assessed based on complaints, physical examination and laboratory data.
Number of clinically significant bleeding on Visits 1-5	up to 29 weeks	The clinically significant bleeding will be considered events ≥ grade 2 according to CTCAE 5.0.
Number and proportion of the patient with antidrug antibodies.	up to 29 weeks	The antidrug antibodies willl be characterized by their type, titer and neutralizing activity.
Number of undesirable events of particular interest in the study (Bleeding;Thrombotic/thromboembolic events)	up to 29 weeks	The event of particular interest in this study are bleeding and thrombotic/thromboembolic events of any location.

Secondary Outcome Measures

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

Trial Locations

Locations (13)

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, Russian Federation

State Budgetary Institution of Healthcare Irkutsk awarded the "Sign of Honor" Order Regional Clinical Hospital; 🇷🇺 Irkutsk, Irkutsk Region, Russian Federation

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, Russian Federation

Llc "Medis"; 🇷🇺 Nizhny Novgorod, Nizhny Novgorod Region, Russian Federation

State Budgetary Health Institution of the Kaluga Region "Kaluga Regional Clinical Hospital"; 🇷🇺 Kaluga, Kaluga Region, Russian Federation

Federal State Budgetary Educational Institution of Higher Education "Novosibirsk State Medical University" of the Ministry of Health of the Russian Federation; 🇷🇺 Novosibirsk, Novosibirsk Region, Russian Federation

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, Russian Federation

State Health Institution of the Tula Region "Tula Regional Clinical Hospital"; 🇷🇺 Tula, Tula Region, Russian Federation

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

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, Russian Federation

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, Russian Federation

Municipal budgetary institution "Central City Hospital No. 7"; 🇷🇺 Ekaterinburg, Russian Federation

Federal State Budgetary Institution "National Medical Research Center named after V.A. Almazov" of the Ministry of Health of the Russian Federation; 🇷🇺 Saint Petersburg, Russian Federation