NCT06376786

Italian iTTP Registry

Italian iTTP Registry (a Prospective Observational Study)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 132 (estimated)
• Sponsor: Fondazione Luigi Villa · Academic / Other
• Sex: All
• Age: 12 Years – 99 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• TTP - Thrombotic Thrombocytopenic Purpura

Timeline

• Start date: 2024-06-20
• Primary completion: 2030-05-31
• Completion: 2030-05-31
• First posted: 2024-04-19
• Last updated: 2024-07-10

Locations

1 site across 1 country: Italy