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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 July 2024 |
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Main ID: |
NCT05492409 |
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Date of registration:
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03/08/2022 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of the Safety and Immunogenicity of Long-term GNR-069 Therapy in ITP Patients
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Scientific title:
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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 |
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Date of first enrolment:
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March 28, 2022 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT05492409 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Russian Federation
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Contacts
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Name:
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Oksana A. Markova, MD, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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AO GENERIUM |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Idiopathic Thrombocytopenic Purpura
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Intervention(s)
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Biological: GNR-069
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Primary Outcome(s)
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Frequency and severity of adverse events associated with the use of the GNR-069
[Time Frame: up to 29 weeks]
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Number of clinically significant bleeding on Visits 1-5
[Time Frame: up to 29 weeks]
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Number of undesirable events of particular interest in the study (Bleeding;Thrombotic/thromboembolic events)
[Time Frame: up to 29 weeks]
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Number and proportion of the patient with antidrug antibodies.
[Time Frame: up to 29 weeks]
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Secondary Outcome(s)
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Platelet count dynamics at Visits 1-5
[Time Frame: up to 5 weeks]
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Frequency of the loss of the treatment response
[Time Frame: up to 27 weeks]
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?hange in ITP-BAT bleeding scores from baseline to week 27
[Time Frame: up to 27 weeks]
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Secondary ID(s)
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RMP-ITP-III-X
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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