Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With ITP

Inclusion criteria

• . 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:
• . 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 criteria