Idiopathic Thrombocytopenic Purpura Clinical Trial
Official title:
Multicenter Randomized Double-blind Comparative Study of Clinical Efficacy and Safety of GNR-069 (JSC "GENERIUM", Russia) and Nplate (Amgen Europe BV, The Netherlands) in Patients With Idiopathic Thrombocytopenic Purpura
Verified date | March 2024 |
Source | AO GENERIUM |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
It is a phase III multicenter randomized double-blinded comparative study of clinical efficacy and safety of GNR-069 and Nplate in patients with idiopathic thrombocytopenic purpura
Status | Completed |
Enrollment | 160 |
Est. completion date | October 19, 2023 |
Est. primary completion date | August 22, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Written Informed Consent Form to participate in the study; 2. Men and women aged 18-75 years inclusive at the time of signing the Informed Consent Form; 3. Documented diagnosis of ITP with a disease duration of more than 12 months from the moment of confirmation of the diagnosis by bone marrow aspirate or biopsy results; 4. A. For patients who have not had splenectomy: - established absence/loss of response to therapy with at least one drug of fist-line treatment for ITP (which include GCs an IVIG); OR - the occurrence of side effects during the course of therapy with the drug of the fist-line, making it impossible to use it further; B. For patients who underwent splenectomy: • loss/lack of response to splenectomy; 5. Thrombocytopenia =30.0 x 109/L - <50.0 x 109/L with severe hemorrhagic syndrome or thrombocytopenia <30.0 x 109/l, regardless of the presence of hemorrhagic syndrome, according to the results of platelet count conducted in a local laboratory for 7 days before the start of therapy with investigational or reference drug; 6. Patients receiving GCs, azathioprine and danazole should receive these drugs in a maintenance dose for at least 4 weeks before starting therapy with investigational or reference drug; 7. Consent of study participants with preserved childbearing function to use reliable methods of contraception (a combination of at least two methods, including 1 barrier method, for example, the use of a condom and spermicide) from the moment of signing the Informed Consent Form and 3 months after the last administration of investigational or reference drug. Exclusion Criteria: 1. Hypersensitivity to the components of investigational or reference drug or E. coli proteins ; 2. Unresolved severe hemorrhagic syndrome requiring emergency treatment at the time of initiation of study or reference drug therapy ; 3. Fisher-Evans Syndrome; 4. Conditions with a high risk of thromboembolic complications ; 5. Myelodysplastic syndrome and/or bone marrow transplantation in anamnesis; 6. Deviations of clinical and laboratory parameters according to the results of studies of blood samples taken during the screening period; 7. Positive test results for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV); 8. Pregnancy or breastfeeding; 9. Use of drugs: - romiplostim used less than 3 weeks before treatment with study or reference drug; - IVIG - less than 2 weeks prior to initiation of study or reference drug therapy; - eltrombopag - used less than 2 weeks before treatment with study or reference drug, or planned to use eltrombopag while the patient is participating in this study; - rituximab - used less than 14 weeks before treatment with study or reference drug, or planned to use rituximab while the patient is enrolled in this study; - cyclophosphamide, cyclosporine, vincristine, vinblastine and other drugs used to treat ITP not listed above and not included in the list of drugs approved for use during the study - use less than 8 weeks before the start of therapy with the study or reference drug or the use of any of these drugs is planned during the patient's participation in this study; - preparations of any hematopoietic growth factors - use less than 8 weeks before the start of therapy with an investigational or reference drug; - Influenza vaccines - less than 21 days prior to start of treatment with study or reference drug; - vaccines to prevent novel coronavirus disease (COVID-19) - completion of the vaccination program less than 21 days prior to the start of study or reference drug therapy; - other vaccines - less than 8 weeks prior to start of treatment with study or reference drug; 10. Splenectomy within 12 weeks prior to screening; 11. Participation in any clinical trials and/or use of unregistered drugs within 4 weeks prior to screening or 5 drug half-lives (whichever is greater); 12. Any other disease or condition that, in the opinion of the investigator, may preclude the patient from participating 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 | State Autonomous Healthcare Institution "Kuzbass Clinical Hospital named after S.V. Belyaev" | Kemerovo | Kemerovo Region |
Russian Federation | Federal State Budgetary Institution "National Medical Research Center for Hematology" of the Ministry of Health of the Russian Federation | 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 health care institution of the city of Moscow "Clinical Hospital named after S.P. Botkin" of the Department of Health of the city of Moscow | Moscow | |
Russian Federation | State Budgetary Health Institution of the Moscow Region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky" | 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 | Federal State Budgetary Educational Institution of Higher Education "Samara State Medical University" of the Ministry of Health of the Russian Federation | Samara | Samara Region |
Russian Federation | Federal State Budgetary Educational Institution of Higher Education "Saratov State Medical University named after V.I. Razumovsky" of the Ministry of Health of the Russian Federation | Saratov | Saratov Region |
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 | Proportion of patients achieving sustained response to treatment | A sustained response to treatment is defined as the number of platelets = 50.0 x 109/L for at least 9 out of 12 consecutive visits during the treatment period with the study or reference drug. | 26 weeks | |
Secondary | Proportion of patients who achieve stable platelet count during treatment with investigational or reference drug | Stable platelet count is defined as the number of platelets = 50.0 x 109/L for at least 4 consecutive weeks without dose adjustment. | 26 weeks | |
Secondary | Time from initiation of therapy with investigational or reference drug to reaching a stable platelet count | 26 weeks | ||
Secondary | Number of cases of emergency therapy for severe hemorrhagic syndrome during the treatment period, starting from the second week of therapy with the investigational or reference drug | 25 weeks | ||
Secondary | Number of clinically significant bleeding episodes during the treatment period, starting from the second week of therapy with investigational or reference drug | Bleeding episode = Grade 2 according to CTCAE version 5.0 is considered clinically significant | 26 weeks | |
Secondary | Change in ITP-specific bleeding assessment tool (ITP-BAT) scores at last visit from baseline at screening | 26 weeks | ||
Secondary | Proportion of patients with no/loss of response to treatment with investigational or reference drug | 26 weeks | ||
Secondary | Proportion of patients receiving approved ITP prophylactic drugs (glucocorticosteroids, azathioprine, danazol) in this study at the time of randomization | 26 weeks |
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