Ignite Creation Date:
2024-07-17 @ 11:13 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497036
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-04
Brief Title:
Study of Efficacy Safety and Immunogenicity of GP40141 GEROPHARM Russia in Patients With Immune Thrombocytopenia
Sponsor:
Geropharm
Organization:
Geropharm
Study Overview
Official Title:
Multicenter Randomized Controlled Study of Efficacy Safety and Immunogenicity of GP40141 GEROPHARM Russia Compared With Nplate Amgen the Netherlands in Patients With Persistent or Early Immune Thrombocytopenia
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to demonstrate equivalent efficacy and comparable safety of the drug GP40141 GEROPHARM Russia in comparison with the drug Nplate Amgen the Netherlands the main questions are
1 Assess the effectiveness of GP40141 in comparison with Nplate
2 Assess the immunogenicity of GP40141 in comparison with the drug Nplate
3 Assess the safety of GP40141 in comparison with the drug Nplate
4 Assess the safety of changing romiplostim and eltrombopag to GP40141
5 Assess the pharmacokinetic parameters of the study drugs in patients with primary immune thrombocytopenia
Participants divided into 2 cohorts naïve or treated with a thrombopoietin receptor agonist will receive romiplostim and platelet response immune response and adverse reactions will be assessed
1 Assess the effectiveness of GP40141 in comparison with Nplate
2 Assess the immunogenicity of GP40141 in comparison with the drug Nplate
3 Assess the safety of GP40141 in comparison with the drug Nplate
4 Assess the safety of changing romiplostim and eltrombopag to GP40141
5 Assess the pharmacokinetic parameters of the study drugs in patients with primary immune thrombocytopenia
Participants divided into 2 cohorts naïve or treated with a thrombopoietin receptor agonist will receive romiplostim and platelet response immune response and adverse reactions will be assessed
Detailed Description:
The study will be conducted in adult patients with persistent or chronic primary immune thrombocytopenia Patients both naïve to treatment with a thrombopoietin receptor agonist cohort 1 and those who have previously received therapy cohort 2 will be included
Cohort 1
Adult steroid-dependent or steroid-refractory patients with persistent or chronic primary immune thrombocytopenia PIT with or without a history of splenectomy who have not previously received thrombopoietin receptor agonist TPO-RA therapy
Cohort 2
Adult patients with persistent or chronic primary immune thrombocytopenia receiving TPO-RA romiplostim or eltrombopag for 12 weeks and with sustained response status at screening
Cohort 1
Adult steroid-dependent or steroid-refractory patients with persistent or chronic primary immune thrombocytopenia PIT with or without a history of splenectomy who have not previously received thrombopoietin receptor agonist TPO-RA therapy
Cohort 2
Adult patients with persistent or chronic primary immune thrombocytopenia receiving TPO-RA romiplostim or eltrombopag for 12 weeks and with sustained response status at screening
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None