Thrombotic Thrombocytopenic Purpura, AcquiredA20iTTPNCT06928233
Association of TNFAIP3 With Immune-mediated TTP
A study testing blood sampling in people with Thrombotic Thrombocytopenic Purpura, Acquired, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
This study aims to investigate whether genetic variation in the TNFAIP3 locus is associated with immune-mediated thrombotic thrombocytopenic purpura (iTTP), and whether such association is mediated by decreased expression of A20 (TNFAIP3). Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thrombotic Thrombocytopenic Purpura, Acquired
- What is being tested?
- blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 7 Apr 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of iTTP
- Above 12 years of age
- Caucasian, Italian origin
- Written informed consent to participate in the study
Who cannot join
- Patients who do not meet the above-listed criteria will be excluded from participation in the study.
- Controls will be healthy Italian volunteers of Caucasian ethnicity, with no history of thrombotic thrombocytopenic purpura, frequency-matched to cases by age and sex, and who have provided written informed consent to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, 20122
Ilaria Mancini, PhD, +390255035414, ilaria.mancini@guest.unimi.it
Ilaria Mancini, PhD
About this study
Official title: Association of the TNFAIP3 Genomic Locus With Immune-mediated TTP
This study aims to investigate whether genetic variation in the TNFAIP3 locus is associated with immune-mediated thrombotic thrombocytopenic purpura (iTTP), and whether such association is mediated by decreased expression of A20 (TNFAIP3). The study includes a case-control design to assess genotype-expression association and a cohort study to evaluate clinical outcomes such as disease relapse.
- Being tested
- blood sampling
- Keywords
- A20, iTTP, TNFAIP3
- Medical subject headings
- Thrombotic thrombocytopenic purpura, acquired
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingProcedure or surgery
Blood sampling for experimental analyses.
| Study group | Role | What they receive |
|---|---|---|
| Patients with iTTP | Other | Intervention: blood sampling during standard collection for routine testing, with additional sample for experimental analyses. Receives: Procedure: blood sampling |
| Healthy donors | Other | Intervention: blood sampling during standard donation, with an additional sample collected for experimental analyses. Receives: Procedure: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allele frequency of TNFAIP3 variants in cases vs controls
Measured: Baseline
Secondary outcomes (5)
TNFAIP3 (A20) mRNA expression levels in peripheral blood
TNFAIP3 (A20) mRNA expression levels in peripheral blood of cases versus controls
Measured: Baseline
Association between TNFAIP3 genotype and gene expression
Measured: Baseline
Clinical relapse rate of iTTP during follow-up
Association between TNFAIP3/A20 variation and iTTP relapse in iTTP patients
Measured: Baseline
Severity of acute iTTP episodes
Association between TNFAIP3/A20 variation and the severity of acute iTTP (composite endpoint including death, treatment refractoriness, exacerbation, and prolonged disease course)
Measured: Baseline
Age at iTTP onset
Association between TNFAIP3/A20 variation and age at onset in iTTP patients
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start7 Apr 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombotic Thrombocytopenic Purpura, AcquiredStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilaria Mancini, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Investigators
- Ilaria Mancini, PhD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928233
- Sponsor's protocol ID
- A20iTTP
- Other IDs
- 2022-0469
- Acronym
- A20iTTP
- Status last verified
- May 2025
- First submitted
- 7 Apr 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of the TNFAIP3 Genomic Locus With Immune-mediated TTP
- ClinicalTrials.gov ID
- NCT06928233
- Acronym / sponsor ID
- A20iTTP / A20iTTP
- Keywords
- A20, iTTP, TNFAIP3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate whether genetic variation in the TNFAIP3 locus is associated with immune-mediated thrombotic thrombocytopenic purpura (iTTP), and whether such association is mediated by decreased expression of A20 (TNFAIP3). The study includes a case-control design to assess genotype-expression association and a cohort study to evaluate clinical outcomes such as disease relapse.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with iTTP | Other | Procedure: blood samplingIntervention: blood sampling during standard collection for routine testing, with additional sample for experimental analyses. |
| Healthy donors | Other | Procedure: blood samplingIntervention: blood sampling during standard donation, with an additional sample collected for experimental analyses. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of iTTP
- Above 12 years of age
- Caucasian, Italian origin
- Written informed consent to participate in the study
Key exclusion criteria (2 listed)
- Patients who do not meet the above-listed criteria will be excluded from participation in the study.
- Controls will be healthy Italian volunteers of Caucasian ethnicity, with no history of thrombotic thrombocytopenic purpura, frequency-matched to cases by age and sex, and who have provided written informed consent to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingBlood sampling for experimental analyses. | Procedure or surgery | Healthy donors, Patients with iTTP |
Primary outcome
Allele frequency of TNFAIP3 variants in cases vs controls
Time frame: Baseline
5 secondary outcomes
TNFAIP3 (A20) mRNA expression levels in peripheral blood
Time frame: Baseline
Association between TNFAIP3 genotype and gene expression
Time frame: Baseline
Clinical relapse rate of iTTP during follow-up
Time frame: Baseline
Severity of acute iTTP episodes
Time frame: Baseline
Age at iTTP onset
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ilaria Mancini, PhD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling in people with Thrombotic Thrombocytopenic Purpura, Acquired, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilaria Mancini, PhD (+390255035414, ilaria.mancini@guest.unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Allele frequency of TNFAIP3 variants in cases vs controls (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.