Idiopathic Thrombocytopenic Purpura Clinical Trial
Official title:
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. ;
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Phase 3 | |
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Phase 4 |