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
Verified date | March 2024 |
Source | AO GENERIUM |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
AO GENERIUM |
Russian Federation,
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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