Clinical trial NCT05492409: 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
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: AO GENERIUM
Sponsor class: INDUSTRY
First posted: 2022-08-08
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Frequency and severity of adverse events associated with the use of the GNR-069
timeFrame: up to 29 weeks
measure: Number of undesirable events of particular interest in the study (Bleeding;Thrombotic/thromboembolic events)
timeFrame: up to 29 weeks
measure: Number of clinically significant bleeding on Visits 1-5
timeFrame: up to 29 weeks
measure: Number and proportion of the patient with antidrug antibodies.
timeFrame: up to 29 weeks
Secondary outcomes:
measure: Frequency of the loss of the treatment response
timeFrame: up to 27 weeks
measure: Platelet count dynamics at Visits 1-5
timeFrame: up to 5 weeks
measure: Сhange in ITP-BAT bleeding scores from baseline to week 27
timeFrame: up to 27 weeks
Other outcomes:
Locations:
city: Irkutsk
country: Russian Federation
facility: State Budgetary Institution of Healthcare Irkutsk awarded the "Sign of Honor" Order Regional Clinical Hospital
state: Irkutsk Region
city: Kaluga
country: Russian Federation
facility: State Budgetary Health Institution of the Kaluga Region "Kaluga Regional Clinical Hospital"
state: Kaluga Region
city: Nizhny Novgorod
country: Russian Federation
facility: State budgetary institution of health care of the Nizhny Novgorod region "Nizhny Novgorod Regional Clinical Hospital named after N. A. Semashko"
state: Nizhny Novgorod Region
city: Nizhny Novgorod
country: Russian Federation
facility: Llc "Medis"
state: Nizhny Novgorod Region
city: Novosibirsk
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education "Novosibirsk State Medical University" of the Ministry of Health of the Russian Federation
state: Novosibirsk Region
city: Ufa
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation
state: Republic Of Bashkortostan
city: Rostov-on-Don
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education "Rostov State Medical University" of the Ministry of Health of the Russian Federation
state: Rostov Region
city: Tula
country: Russian Federation
facility: State Health Institution of the Tula Region "Tula Regional Clinical Hospital"
state: Tula Region
city: Ekaterinburg
country: Russian Federation
facility: Municipal budgetary institution "Central City Hospital No. 7"
city: Moscow
country: Russian Federation
facility: 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
country: Russian Federation
facility: Federal State Budget Funded Institution National Medical Research Center of Hematology, Ministry of Health of the Russian Federation (MoH of Russia)
city: Moscow
country: Russian Federation
facility: 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: Saint Petersburg
country: Russian Federation
facility: Federal State Budgetary Institution "National Medical Research Center named after V.A. Almazov" of the Ministry of Health of the Russian Federation
Study officials:
affiliation: AO GENERIUM
name: Oksana A. Markova, MD, MSc
role: STUDY_CHAIR
References: