Status:
COMPLETED
Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With ITP
Lead Sponsor:
AO GENERIUM
Conditions:
Idiopathic Thrombocytopenic Purpura
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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
Detailed Description
The drug GNR-069(JSC "GENERIUM", Russia) is biosimilar to the original drug Nplate. This study is aimed to compare the clinical efficacy and safety of the drug GNR-069 and the drug Nplate to register ...
Eligibility Criteria
Inclusion
- Written Informed Consent Form to participate in the study;
- Men and women aged 18-75 years inclusive at the time of signing the Informed Consent Form;
- 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;
- 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;
- 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;
- 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;
- 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
- Hypersensitivity to the components of investigational or reference drug or E. coli proteins ;
- Unresolved severe hemorrhagic syndrome requiring emergency treatment at the time of initiation of study or reference drug therapy ;
- Fisher-Evans Syndrome;
- Conditions with a high risk of thromboembolic complications ;
- Myelodysplastic syndrome and/or bone marrow transplantation in anamnesis;
- Deviations of clinical and laboratory parameters according to the results of studies of blood samples taken during the screening period;
- Positive test results for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV);
- Pregnancy or breastfeeding;
- 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;
- Splenectomy within 12 weeks prior to screening;
- 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);
- Any other disease or condition that, in the opinion of the investigator, may preclude the patient from participating in the study.
Key Trial Info
Start Date :
September 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2023
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT05220878
Start Date
September 9 2021
End Date
October 19 2023
Last Update
March 6 2024
Active Locations (18)
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1
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, 450008
2
State Budgetary Institution of Healthcare Irkutsk awarded the "Sign of Honor" Order Regional Clinical Hospital
Irkutsk, Irkutsk Oblast, Russia, 664079
3
State Budgetary Health Institution of the Kaluga Region "Kaluga Regional Clinical Hospital"
Kaluga, Kaluga Oblast, Russia, 248007
4
State Autonomous Healthcare Institution "Kuzbass Clinical Hospital named after S.V. Belyaev"
Kemerovo, Kemerovo Oblast, Russia, 650066