Idiopathic Thrombocytopenic Purpura
Conditions
Keywords
Idiopathic thrombocytopenic purpura, ITP, Thrombocytopenia, Thrombocytopoiesis, Bleeding, Hemorrhagic syndrome, Petechial rash, Ecchymosis, Fc-peptide, Recombinant DNA technology, Thrombopoietin receptors, Platelet formation, Fc fragment of human immunoglobulin IgG 1, Low platelet count, ITP treatment, Platelets, Haemorrhage, Platelet destruction, Impaired thrombopoiesis, Megakaryocytes, Autoantibodies, Splenectomy, Cytotoxic, T cells, Thrombopoietin receptor agonists, Thrombopoietin receptor mimetic, TPO-RAs, romiplostim, Nplate
Brief 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
Detailed 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.
Interventions
BIOLOGICALGNR-069
Once a week as a subcutaneous injection.
Sponsors
AO GENERIUM
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and severity of adverse events associated with the use of the GNR-069 | up to 29 weeks | Adverse events will be assessed based on complaints, physical examination and laboratory data. |
| Number of undesirable events of particular interest in the study (Bleeding;Thrombotic/thromboembolic events) | up to 29 weeks | The event of particular interest in this study are bleeding and thrombotic/thromboembolic events of any location. |
| Number of clinically significant bleeding on Visits 1-5 | up to 29 weeks | The clinically significant bleeding will be considered events ≥ grade 2 according to CTCAE 5.0. |
| Number and proportion of the patient with antidrug antibodies. | up to 29 weeks | The antidrug antibodies willl be characterized by their type, titer and neutralizing activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Platelet count dynamics at Visits 1-5 | up to 5 weeks | The platalets must be counted till week 5 |
| Сhange in ITP-BAT bleeding scores from baseline to week 27 | up to 27 weeks | ITP-specific bleeding assessment tool (ITP-BAT) will be calculated at baseline and at week 27. |
| Frequency of the loss of the treatment response | up to 27 weeks | 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. |
Countries
Russia
Outcome results
None listed