Study of the Safety and Immunogenicity of Long-term GNR-069 Therapy in ITP Patients

Extension Study of Long-term Safety and Immunogenicity of GNR-069 Patients With Idiopathic Thrombocytopenic Purpura Who Completed Phase 3 RMP-ITP-III Clinical Trial

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:

• 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.

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