Study of the Safety and Immunogenicity of Long-term GNR-069 Therapy in ITP Patients
NCT ID: NCT05492409
Last Updated: 2024-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
160 participants
INTERVENTIONAL
2022-03-28
2024-04-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GNR-069
Weekly subcutaneous injections of GNR-069 in the individually titrated dose.
GNR-069
Once a week as a subcutaneous injection.
Interventions
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GNR-069
Once a week as a subcutaneous injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy or breastfeeding;
* Any diseases and conditions that, in the opinion of the Investigator, may hinder the patient's participation in the study
18 Years
75 Years
ALL
No
Sponsors
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AO GENERIUM
INDUSTRY
Responsible Party
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Principal Investigators
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Oksana A. Markova, MD, MSc
Role: STUDY_CHAIR
AO GENERIUM
Locations
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Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation
Ufa, Bashkortostan Republic, Russia
State Budgetary Institution of Healthcare Irkutsk awarded the "Sign of Honor" Order Regional Clinical Hospital
Irkutsk, Irkutsk Oblast, Russia
State Budgetary Health Institution of the Kaluga Region "Kaluga Regional Clinical Hospital"
Kaluga, Kaluga Oblast, Russia
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, Russia
Llc "Medis"
Nizhny Novgorod, Nizhny Novgorod Oblast, Russia
Federal State Budgetary Educational Institution of Higher Education "Novosibirsk State Medical University" of the Ministry of Health of the Russian Federation
Novosibirsk, Novosibirsk Oblast, Russia
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, Russia
State Health Institution of the Tula Region "Tula Regional Clinical Hospital"
Tula, Tula Oblast, Russia
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, , Russia
Federal State Budget Funded Institution National Medical Research Center of Hematology, Ministry of Health of the Russian Federation (MoH of Russia)
Moscow, , 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"
Moscow, , Russia
Federal State Budgetary Institution "National Medical Research Center named after V.A. Almazov" of the Ministry of Health of the Russian Federation
Saint Petersburg, , Russia
Municipal budgetary institution "Central City Hospital No. 7"
Yekaterinburg, , Russia
Countries
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Other Identifiers
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RMP-ITP-III-X
Identifier Type: -
Identifier Source: org_study_id
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