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

Idiopathic Thrombocytopenic Purpura Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05492409
• Other study ID #: RMP-ITP-III-X
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: March 28, 2022
• Est. completion date: April 3, 2024

Study information

• Verified date: March 2024
• Source: AO GENERIUM
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 160
• Est. completion date: April 3, 2024
• Est. primary completion date: April 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Biological:
• GNR-069
Once a week as a subcutaneous injection.

Locations

Country	Name	City	State
Russian Federation	Municipal budgetary institution "Central City Hospital No. 7"	Ekaterinburg
Russian Federation	State Budgetary Institution of Healthcare Irkutsk awarded the "Sign of Honor" Order Regional Clinical Hospital	Irkutsk	Irkutsk Region
Russian Federation	State Budgetary Health Institution of the Kaluga Region "Kaluga Regional Clinical Hospital"	Kaluga	Kaluga 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	Llc "Medis"	Nizhny Novgorod	Nizhny Novgorod 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	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 "Rostov State Medical University" of the Ministry of Health of the Russian Federation	Rostov-on-Don	Rostov Region
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	State Health Institution of the Tula Region "Tula Regional Clinical Hospital"	Tula	Tula 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

Sponsors (1)

Lead Sponsor	Collaborator
AO GENERIUM

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Frequency of the loss of the treatment response	Loss of the treatment response is assessed as absense of platelet increase = 50,0 ? 109/L on the 4 weeks treatment with maximal study drug dose.	up to 27 weeks
Secondary	Platelet count dynamics at Visits 1-5	The platalets must be counted till week 5	up to 5 weeks
Secondary	?hange 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.	up to 27 weeks