Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568913
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
The Outcome of the Thrombopoietin Receptor Agonists in Pediatric Patient With Persistent or Chronic ITP Unresonsive to Steroids
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Outcome of the Thrombopoietin Receptor Agonists in Pediatric Patient With Persistent or Chronic ITP Unresonsive to Steroids
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Immune thrombocytopenic purpura ITP is an autoimmune disease characterized by a low platelet count purpura and hemorrhagic episodes caused by antiplatelet autoantibodies The diagnosis is typically made by excluding the known causes of thrombocytopenia IgG autoantibodies sensitize the circulating platelets It leads to the accelerated removal of these cells by antigen-presenting cells macrophages of the spleen and sometimes the liver or other components of the monocyte-macrophage system The bone marrow compensates for platelet destruction by increasing platelet production ITP most often occurs in healthy children and young adults within a few weeks following a viral infection
New treatment guidelines have supported a shift from corticosteroids and splenectomy to newer medical treatments that mitigate the thrombocytopenia and avoid splenectomy The thrombopoietin receptor agonists TPO-RA romiplostim eltrombopag have markedly altered the treatment of ITP
The thrombopoietin receptor agonists TPO-Ras romiplostim and eltrombopag have shown high therapeutic activity In primary ITP
Romiplostim a thrombopoiesis-stimulating peptibody represents a new therapeutic option in adult refractory chronic immune thrombocytopenia ITP This study aimed to assess the short-term efficacy and safety of romiplostim in children withChronic ITP
The most commonly reported drug-related adverse effects include headache nausea and hepatobiliary laboratory abnormalities Long-term safety data in children are limited and studies in adults have not revealed a clinically significant increased incidence of thrombosis marrow fibrosis or cataract formation
TPO-RA do not need to be continued forever about a third of patients In the first year and about another third after two years have a remission Whether TPO-RA affect the ITP pathophysiology and directly cause remission remains unclear This review provides a personal overview of the diagnosis and treatment of ITP with a focus on the mechanism of action of TPO-RA their place in the treatment algorithm unique aspects of their clinical use adverse effects
New treatment guidelines have supported a shift from corticosteroids and splenectomy to newer medical treatments that mitigate the thrombocytopenia and avoid splenectomy The thrombopoietin receptor agonists TPO-RA romiplostim eltrombopag have markedly altered the treatment of ITP
The thrombopoietin receptor agonists TPO-Ras romiplostim and eltrombopag have shown high therapeutic activity In primary ITP
Romiplostim a thrombopoiesis-stimulating peptibody represents a new therapeutic option in adult refractory chronic immune thrombocytopenia ITP This study aimed to assess the short-term efficacy and safety of romiplostim in children withChronic ITP
The most commonly reported drug-related adverse effects include headache nausea and hepatobiliary laboratory abnormalities Long-term safety data in children are limited and studies in adults have not revealed a clinically significant increased incidence of thrombosis marrow fibrosis or cataract formation
TPO-RA do not need to be continued forever about a third of patients In the first year and about another third after two years have a remission Whether TPO-RA affect the ITP pathophysiology and directly cause remission remains unclear This review provides a personal overview of the diagnosis and treatment of ITP with a focus on the mechanism of action of TPO-RA their place in the treatment algorithm unique aspects of their clinical use adverse effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None