NCT05492409

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: AO GENERIUM · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Thrombocytopenic Purpura

Interventions

Type	Name	Description
BIOLOGICAL	GNR-069	Once a week as a subcutaneous injection.

Timeline

• Start date: 2022-03-28
• Primary completion: 2024-04-03
• Completion: 2024-04-03
• First posted: 2022-08-08
• Last updated: 2024-06-21

Locations

13 sites across 1 country: Russia