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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Sponsor
- AO GENERIUM
- Enrollment
- 160
- Locations
- 13
- Primary Endpoint
- Frequency and severity of adverse events associated with the use of the GNR-069
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Frequency and severity of adverse events associated with the use of the GNR-069
Time Frame: up to 29 weeks
Adverse events will be assessed based on complaints, physical examination and laboratory data.
Number of clinically significant bleeding on Visits 1-5
Time Frame: 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.
Time Frame: up to 29 weeks
The antidrug antibodies willl be characterized by their type, titer and neutralizing activity.
Number of undesirable events of particular interest in the study (Bleeding;Thrombotic/thromboembolic events)
Time Frame: up to 29 weeks
The event of particular interest in this study are bleeding and thrombotic/thromboembolic events of any location.
Secondary Outcomes
- Frequency of the loss of the treatment response(up to 27 weeks)
- Platelet count dynamics at Visits 1-5(up to 5 weeks)
- Сhange in ITP-BAT bleeding scores from baseline to week 27(up to 27 weeks)