Who may be eligible for the Italian iTTP Registry trial?

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

ClinicalTrials.gov record NCT06376786

Italian iTTP Registry

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

Italian iTTP Registry (a Prospective Observational Study)

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.The registry record was last updated on Jul 10, 2024, about 2 years ago, so the status shown may be out of date. The study team or the registry can confirm.

Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.

Age12 years old and older

SexAll

LocationItaly

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

A national, prospective, non‑pharmacological registry of people hospitalized with acute immune‑mediated TTP (first episode or relapse). It will collect routine clinical and laboratory data and blood samples for ADAMTS13 testing and possible future research. Planned enrollment is at least 132 participants aged 12–99 with about 3 years of follow-up.

What it is studying. The study is testing (observing) the natural history, disease severity, treatments used, laboratory findings including ADAMTS13, and short- and long-term outcomes of people with acute iTTP.

What the researchers hope to learn. To describe the natural history and incidence of iTTP; to document clinical presentation, triggering factors, laboratory patterns (including ADAMTS13 activity and antibodies), treatments used, remission and relapse rates, complications (including pregnancy-related), and adverse events related to TTP therapies; and to improve understanding of long-term outcomes.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive usual clinical care for their acute iTTP while enrolled. During hospitalization and at outpatient visits they will have routine clinical assessments and laboratory tests, and peripheral blood samples will be collected for ADAMTS13 analysis and potential future research. They will be followed for up to three years. Participation requires signing the study informed consent.

How the study is structured. A prospective, multicenter observational cohort study. Patients hospitalized for an acute iTTP episode are enrolled and followed in outpatient clinics. No experimental treatments are assigned; participants receive standard clinical care. The study collects routine clinical assessments, laboratory tests, and peripheral blood samples for ADAMTS13 analysis and potential future research, with about three years of follow-up.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
The listed sites are in Italy. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on thrombotic thrombocytopenic purpura

Clinical trials18 trials listed for thrombotic thrombocytopenic purpuraEvery trial the registry lists for thrombotic thrombocytopenic purpura, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in thrombotic thrombocytopenic purpura researchLatest monthly update: September 2026. Includes: Caplacizumab use. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Jun 20, 2024
Primary completion: May 31, 2030 (estimated)
Study completion: May 31, 2030 (estimated)
Target enrollment: 132 participants (estimated)
Last updated on registry: Jul 10, 2024
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Fondazione Luigi Villa

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Sandra Maccarone 📞 +39 02 551 0709 ✉ contact@fondazioneluigivilla.org
Ilaria Mancini, MSc, PhD 📞 +39 02 5503 5414 ✉ ilaria.mancini@guest.unimi.it

Participating sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoRecruiting
Milan, MI, 20122 · Italy

Terms used on this page · explanations by MedicalUpdates.ai

single-arm: All participants receive the same treatment or follow the same plan. There is no comparison group within the study.
cohort study: A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
natural history: A study that follows how a condition changes over time without assigning an experimental treatment. It may involve study visits and tests, and is often used to plan future trials.
relapse: A condition that improved with treatment and has since returned or worsened.
follow-up: The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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