Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376786
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-03-15
Brief Title:
Italian iTTP Registry
Sponsor:
Fondazione Luigi Villa
Organization:
Fondazione Luigi Villa
Study Overview
Official Title:
Italian iTTP Registry a Prospective Observational Study
Status:
RECRUITING
Status Verified Date:
2024-04
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:
ItaliTTP is an observational prospective single-arm national multicenter non-pharmacological cohort study aimed at better defining and understanding the natural history disease severity and clinical outcomes of patients with immune-mediated thrombotic thrombocytopenic purpura iTTP in Italy
A minimum of 132 consecutive patients with acute iTTP first event or relapse will be enrolled for 3 years with the possibility of extension with a follow-up period of 3 years
A minimum of 132 consecutive patients with acute iTTP first event or relapse will be enrolled for 3 years with the possibility of extension with a follow-up period of 3 years
Detailed Description:
Acquired immune-mediated thrombotic thrombocytopenic purpura iTTP is a rare life-threatening thrombotic microangiopathy characterized by episodes of thrombocytopenia microangiopathic hemolytic anemia and extensive microvascular thrombosis leading to multiorgan involvement Despite advances in understanding iTTP etiology and management in the acute phase significant gaps in knowledge about its progression particularly during clinical remission and concerning long-term complications persist
ItaliTTP a national multicenter observational prospective non-pharmacological cohort study aims to elucidate the natural history severity and outcomes of iTTP in Italy The study will enroll hospitalized iTTP patients experiencing either initial or recurrent episodes and follow them in outpatient settings across participating Italian centers The study plans to include at least 132 patients of any gender aged 12 to 99 over a three-year period with an option for extension and a three-year follow-up During hospitalization and subsequent outpatient visits participants will undergo routine clinical assessments and laboratory tests In addition to these data peripheral blood samples will be collected for ADAMTS13 analysis and potential future research
ItaliTTP a national multicenter observational prospective non-pharmacological cohort study aims to elucidate the natural history severity and outcomes of iTTP in Italy The study will enroll hospitalized iTTP patients experiencing either initial or recurrent episodes and follow them in outpatient settings across participating Italian centers The study plans to include at least 132 patients of any gender aged 12 to 99 over a three-year period with an option for extension and a three-year follow-up During hospitalization and subsequent outpatient visits participants will undergo routine clinical assessments and laboratory tests In addition to these data peripheral blood samples will be collected for ADAMTS13 analysis and potential future research
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