Registry for patients with immune-mediated thrombotic thrombocytopenic purpura in Italy
Italian iTTP Registry (a Prospective Observational Study)
This study is tracking patients with immune-mediated thrombotic thrombocytopenic purpura in Italy to see how the disease affects them over time and what their treatment outcomes are.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 132 (estimated) |
| Ages | 12 Years to 99 Years |
| Sex | All |
| Sponsor | Fondazione Luigi Villa Academic / other |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT06376786 on ClinicalTrials.gov |
What this trial studies
The ItaliTTP registry is an observational, prospective, multicenter study that aims to better understand the natural history and clinical outcomes of patients with immune-mediated thrombotic thrombocytopenic purpura (iTTP) in Italy. It will enroll at least 132 patients experiencing either their first episode or a relapse of iTTP over a three-year period, with follow-up extending for another three years. Participants will undergo routine clinical assessments and laboratory tests, including ADAMTS13 analysis, to gather comprehensive data on disease severity and progression.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 12 years or older who are experiencing an acute episode of iTTP with severe ADAMTS13 deficiency.
Not a fit: Patients who do not have an acute episode of iTTP or have not signed the informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term management and outcomes of patients with iTTP, potentially improving patient care.
How similar studies have performed: While there have been studies on iTTP, this registry approach is novel in its comprehensive, multicenter observational design focused on long-term outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with an acute iTTP episode (first event or relapse), defined by thrombocytopenia and microangiopathic hemolytic anemia, in the absence of alternative causes, and the presence of severe deficiency of ADAMTS13 activity (\< 10 IU/dL or \<10% of normal value) and anti-ADAMTS13 autoantibodies * Both male and female patients, aged 12 years or older * Patients who have signed the informed consent for the participation to the study Exclusion Criteria: * Patients who have not signed the informed consent for the participation to the study
Where this trial is running
Milan, MI
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Mi, Italy (Recruiting)
Study contacts
- Principal investigator: Flora Peyvandi, MD, PhD — Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy
- Study coordinator: Sandra Maccarone
- Email: contact@fondazioneluigivilla.org
- Phone: +39 02 551 0709
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.