Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06137105
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-11-05
Brief Title:
Thrombopoietin Agonists in Patients With Idiopathic Thrombocytopenic Purpura
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
A Study of Treatment With Thrombopoietin Agonists in Patients With Idiopathic Thrombocytopenic Purpura
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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:
1 Assesement of response to Thrombopoietin receptor agonists TPO-RAs as treatment in Idiopathic thrombocytopenia purpura patients in Assiut University hospital
2 Explore side effects of Thrombopoietin receptor agonists in Idiopathic thrombocytopenia purpura
3 To study effect of thrombopoietin receptor agonists and Quality life in Idiopathic thrombocytopenia purpura patients
2 Explore side effects of Thrombopoietin receptor agonists in Idiopathic thrombocytopenia purpura
3 To study effect of thrombopoietin receptor agonists and Quality life in Idiopathic thrombocytopenia purpura patients
Detailed Description:
Idiopathic thrombocytopenic purpura ITP is an autoimmune disorder characterized by reduced platelet counts 100 109L and increased bleeding risk in the absence of other causes associated with thrombocytopenia It affects 2-4 per 100000 individuals annually with an overall prevalence of about 10100000 individuals
Manifestations of idiopathic thrombocytopenic purpura ITP can be localised haemorrhaging in skin or mucous membranes that are usually of little to no clinical consequence petechiae purpura ecchymoses epistaxis more rarely ITP can be associated with severe bleeding events such as intracranial haemorrhage ICH However most ITP patients are asymptomatic in the presence of platelet counts greater than 50x109L2
Idiopathic thrombocytopenia purpura is diagnosed in absence of secondary causes of immune mediated thrombocytopenia including autoimmune diseases systemic lupus erthematosus antiphospholipid antibody syndrome lymphoproliferative disorders chronic lymphocytic leukemia viral infection hepatitis c virus human immunodeficiency virus
The goal of treatment in patients with of idiopathic thrombocytopenic purpura is to maintain the platelet count at a level that reduces the risk of bleeding with minimal treatment-related toxic effects Observation alone is recommended when no or mild bleeding is present and the platelet count is more than 30000 per cubic millimeter in adults23 Treatment in patients with a lower platelet count is indicated only if bleeding occurs or if the platelet count is very low For example most experts would treat a non bleeding patient who had a platelet count of 10000 per cubic millimeter
Historically the treatment of idiopathic thrombocytopenia purpura has been directed at inhibiting the production of anti platelet autoantibodies or opsonization of antibody coated platelets However impaired platelet production is increasingly recongnized as a contributor to thrombocytopenia in patients with idiopathic thrombocytopenia purpura
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 and avatrombopag have markedly altered the treatment of ITP
Thrombopoietin TPO is the main cytokine that stimulates thrombopoiesis and although platelet counts are low in ITP patients no compensatory increase in TPO production occurs in these patients
Thrombopoietin receptor agonists TPO-RAs are TPO mimetics that can bind to and activate TPO receptors leading to megakaryocyte maturation proliferation and differentiation and resulting in increased platelet production Two major TPO-RAs romiplostim and eltrombopag have been investigated in several randomized controlled trials RCTs involving adult and pediatric ITP patients the results of which are encouraging Currently romiplostim and eltrombopag are recommended as second-line therapeutic options for adult ITP patients
Manifestations of idiopathic thrombocytopenic purpura ITP can be localised haemorrhaging in skin or mucous membranes that are usually of little to no clinical consequence petechiae purpura ecchymoses epistaxis more rarely ITP can be associated with severe bleeding events such as intracranial haemorrhage ICH However most ITP patients are asymptomatic in the presence of platelet counts greater than 50x109L2
Idiopathic thrombocytopenia purpura is diagnosed in absence of secondary causes of immune mediated thrombocytopenia including autoimmune diseases systemic lupus erthematosus antiphospholipid antibody syndrome lymphoproliferative disorders chronic lymphocytic leukemia viral infection hepatitis c virus human immunodeficiency virus
The goal of treatment in patients with of idiopathic thrombocytopenic purpura is to maintain the platelet count at a level that reduces the risk of bleeding with minimal treatment-related toxic effects Observation alone is recommended when no or mild bleeding is present and the platelet count is more than 30000 per cubic millimeter in adults23 Treatment in patients with a lower platelet count is indicated only if bleeding occurs or if the platelet count is very low For example most experts would treat a non bleeding patient who had a platelet count of 10000 per cubic millimeter
Historically the treatment of idiopathic thrombocytopenia purpura has been directed at inhibiting the production of anti platelet autoantibodies or opsonization of antibody coated platelets However impaired platelet production is increasingly recongnized as a contributor to thrombocytopenia in patients with idiopathic thrombocytopenia purpura
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 and avatrombopag have markedly altered the treatment of ITP
Thrombopoietin TPO is the main cytokine that stimulates thrombopoiesis and although platelet counts are low in ITP patients no compensatory increase in TPO production occurs in these patients
Thrombopoietin receptor agonists TPO-RAs are TPO mimetics that can bind to and activate TPO receptors leading to megakaryocyte maturation proliferation and differentiation and resulting in increased platelet production Two major TPO-RAs romiplostim and eltrombopag have been investigated in several randomized controlled trials RCTs involving adult and pediatric ITP patients the results of which are encouraging Currently romiplostim and eltrombopag are recommended as second-line therapeutic options for adult ITP patients
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