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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05492409
Other study ID # RMP-ITP-III-X
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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 Completed
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

Study Design


Related Conditions & MeSH terms


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
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