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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GNR-069 | Experimental | Weekly subcutaneous injections of GNR-069 in the individually titrated dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GNR-069 | Biological | Once a week as a subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of the loss of the treatment response | Loss of the treatment response is assessed as absense of platelet increase ≥ 50,0 х 109/L on the 4 weeks treatment with maximal study drug dose. | up to 27 weeks |
| Platelet count dynamics at Visits 1-5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oksana A. Markova, MD, MSc | AO GENERIUM | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry of Health of the Russian Federation | Ufa | Bashkortostan Republic | 450008 | Russia |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| D013921 | Thrombocytopenia |
| D006470 | Hemorrhage |
| D011693 | Purpura |
| D004438 | Ecchymosis |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C488777 | romiplostim |
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The platalets must be counted till week 5
| up to 5 weeks |
| Сhange 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 |
| State Budgetary Institution of Healthcare Irkutsk awarded the "Sign of Honor" Order Regional Clinical Hospital | Irkutsk | Irkutsk Oblast | 664079 | Russia |
| State Budgetary Health Institution of the Kaluga Region "Kaluga Regional Clinical Hospital" | Kaluga | Kaluga Oblast | 248007 | 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 | 603126 | Russia |
| Llc "Medis" | Nizhny Novgorod | Nizhny Novgorod Oblast | 603137 | 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 | 630091 | 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 | 344022 | Russia |
| State Health Institution of the Tula Region "Tula Regional Clinical Hospital" | Tula | Tula Oblast | 300053 | 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 | 111123 | Russia |
| Federal State Budget Funded Institution National Medical Research Center of Hematology, Ministry of Health of the Russian Federation (MoH of Russia) | Moscow | 125167 | 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 | 127644 | 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 | 191014 | Russia |
| Municipal budgetary institution "Central City Hospital No. 7" | Yekaterinburg | 620137 | Russia |
| D057049 | Thrombotic Microangiopathies |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |