Idiopathic Thrombocytopenic PurpuraITP0918NCT03465020
Investigation on a Dynamic Cohort of Italian Patients With Active ITP
An observational study of Idiopathic Thrombocytopenic Purpura, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 26 sites in Italy.
Trial summary
The objective of the study is to produce a dynamic picture of the adult ITP natural history and management in Italy by collecting standardized information retrospective and prospective data of patients in active management through a nation-wide registry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Thrombocytopenic Purpura
- What is being tested?
- Observation
- How many people
- 861 participants
- Where
- 26 sitesItaly
- Study dates
- 15 Oct 2018to Jul 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Study population: All consecutive adult patients (18 years or older) in active treatment for ITP meeting one of the three conditions at their first visit after the enrolment has been opened. In all cases, patients should be enrolled at the first visit during the enrolment period (or at latest within 1 month with data referred back to the first visit).
Who may be able to join
- Patients never treated before for whom an ITP treatment is initiated for the first time by the recruiting center
- Patients already treated for whom a new line of ITP treatment is initiated by the recruiting center (the patients could have been treated elsewhere before)
- Patients who, under any ITP treatment at the recruiting center.
Who cannot join
- -Undefined
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Italy26 sites, 26 recruiting
- Recruiting
Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica
Ancona
Antonella Poloni, a.poloni@univpm.it
- Recruiting
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Bari
Alessandra Ricco, alericcomd@gmail.com
- Recruiting
Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia
Bologna
Nicola Vianelli, nicola.vianelli@unibo.it
- Recruiting
Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo
Cagliari
Maria Pina Simula, mariap.simula@aob.it
- Recruiting
Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania
Capranica
Francesco Di Raimondo, diraimon@unict.it
- Recruiting
Arnas Garibaldi, Po Garibaldi-Nesima - Catania - Uoc Ematologia
Catania
Ugo Consoli, ugo.consoli144@gmail.com
- Recruiting
Aou Careggi - Firenze - Sod Ematologia
Florence
Valentina Carrai, carraiv@aou-careggi.toscana.it
- Recruiting
Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia
Milan
Silvia Cantoni, silvia.cantoni@ospedaleniguarda.it
- Recruiting
Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
Milan
Wilma Barcellini, wilma.barcellini@policlinico.mi.it
- Recruiting
Asst Di Monza, Ospedale S. Eugenio - Uo Ematologia E Cta
Monza
Monica Carpenedo, mnc.carpenedo@gmail.com
- Recruiting
Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo
Naples
Felicetto T Ferrara, felicettoferrara@katamail.com
- Recruiting
Aou Federico Ii - Napoli - Uoc Ematologia
Naples
Fabrizio U Pane, fabrizio.pane@unina.it
- Recruiting
Aou Maggiore Della Carita' Di Novara - Scdu Ematologia
Novara
Gianluca Gaidano, gianluca.gaidano@med.uniupo.it
- Recruiting
Aou Policlinico P. Giaccone - Palermo - Uo Ematologia
Palermo
Sergio Siragusa, sergio.siragusa@unipa.it
- Recruiting
Sc Ematologia E Centro Trapianti Midollo Osseo
Parma, SC
Crugnola
- Recruiting
Ospedale S.M. della Misericordia - STROKE UNIT
Perugia
Gresele
- Recruiting
Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti
Piacenza
Costanza Bosi, costanza.bosi@tiscali.it
- Recruiting
Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia
Reggio Emilia
Elena Rivolti, rivolti.elena@ausl.re.it
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
Roma
Elena Rossi, elena.rossi@rm.unicatt.it
- Recruiting
Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
San Giovanni Rotondo
Potito Rosario Scanzulli, p.scalzulli@operapadrepio.it
- Recruiting
Asl Taranto, Ospedale Ss. Annunziata - Uoc Ematologia
Taranto
Patrizio Mazza, patrizio.mazza@libero.it
- Recruiting
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
Torino
Alessandra Borchiellini, alesandre@libero.it
- Recruiting
Ente Ecclesiastico Cardinale G. Panico - Tricase - Uo Ematologia
Tricase
Vincenzo Pavone, ematologia@piafondazionepanico.it
- Recruiting
Azienda Sanitaria Universitaria Integrata Di Trieste - Sc Ematologia
Trieste
Francesco S Zaja, francesco.zaja@asuits.sanita.fvg.it
- Recruiting
Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica
Udine
Davide Lazzarotto, davide.lazzarotto@asufc.sanita.fvg.it
- Recruiting
Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia
Vicenza
Marco Ruggeri
About this study
Official title: ITALIAN ADULT IMMUNE THROMBOCYTOPENIA (ITP) REGISTRY Investigation on a Dynamic Cohort of Italian Patients With Active ITP
The objective of the study is to produce a dynamic picture of the adult ITP natural history and management in Italy by collecting standardized information retrospective and prospective data of patients in active management through a nation-wide registry.
Read the detailed description
Primary immune thrombocytopenia (ITP) is an acquired autoimmune disorder affecting both children and adults, characterized by a platelet count below 100 x 109/L in the absence of any underlying disease explaining the thrombocytopenia. Clinical manifestations may be absent or include cutaneous mucosal or organ bleeding, resulting in an overall mortality rate of less than 1-2%.
Previously, 'acute ITP' was used to describe a self-limited form of the disease and 'chronic ITP' to describe the disease if it lasted for more than 6 months. In 2009, a new terminology for ITP was agreed upon based on the duration of the disease. The new terms for ITP are: 'newly diagnosed ITP (from diagnosis to 3 months), 'persistent ITP' (3-12 months) and 'chronic ITP' (lasting for more than 12 months) [2].
Chronic primary ITP in adults is slightly more common in women of childbearing age but the sex incidence is similar in patients over 60. The incidence of ITP in adults is around 4 per 100.000 people per year, with a UK prevalence of up to 24 per 100.000 people [4-6]. No more than 2 per 100.000 will require ITP treatment.
Bleeding is highly variable and there is great heterogeneity. Bleeding is most commonly mucocutaneous, involving the skin and subcutaneous tissue (petechiae, ecchymoses, subcutaneous hematomas), the external mucosae (epistaxis, gum bleeding, blood blisters in the mouth), muscles (muscle hematomata) or the various organs and internal mucosae (hematuria, gastrointestinal bleeding, menorrhagia, intracerebral bleeding). Major bleeding is not common if the platelet count is above 30x109/L. Intracranial hemorrhage is rare and is most often seen in older patients who have additional comorbidities and in patients who fail to respond to therapy. The yearly risk of fatal hemorrhage is around 1.6-3.9% in unresponsive patients. This risk varies with age, from 0.4% per year in patients below 40 years old to 13% per year in those over 60. The natural history of ITP with currently available treatments is not well known. Available data are mostly based on the era when rituximab and thrombopoietin-receptor agonists (TPO-RA) were not in use.
There is a lack reliable data on how recent treatments have modified the course of the disease. Bleeding frequency and severity, complications like infections, thrombosis, ITP-related symptoms like fatigue, etc. are also largely unknown as are women's related issues. Similarly, the cost of treatment for a patient with ITP is not available. Safety and efficacy of specific recent treatments have been measured mostly in industry-sponsored studies. Furthermore, most studies did not conform to the International Working Group (IWG) on ITP recommendations concerning terminology, definitions, outcome criteria and assessment of bleeding.
To the investigator's knowledge, an ITP Registry is ongoing in UK and in Australia and registries are being planned in other European countries with a prospective of creating an international network. The only established international registry, the ITP PARC study, is operative since 2004 but covers different aspects of the disease. The few Italian registries are of regional dimension and are not aligned to collect standardized information in a uniform way.
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Being tested
- Observation
- Keywords
- Idiopathic, Thrombocytopenic, Purpura
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Purpura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Safety and efficacy outcomes of patients on different treatments
| Study group | Role | What they receive |
|---|---|---|
| ITP patients | On active treatment Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events in ITP adult patients
Measured: After 36 months from study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start15 Oct 2018
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 861 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Progetto Ematologia
- Responsible party
- Sponsor
- Investigators
- Francesco Rodeghiero, Study chair, Department of Hematology, S. Bortolo Hospital of VicenzaMarco Ruggeri, Study director, Department of Hematology, S. Bortolo Hospital, Vicenza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465020
- Sponsor's protocol ID
- ITP0918
- Acronym
- ITP0918
- Status last verified
- Jul 2022
- First submitted
- 8 Mar 2018
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ITALIAN ADULT IMMUNE THROMBOCYTOPENIA (ITP) REGISTRY Investigation on a Dynamic Cohort of Italian Patients With Active ITP
- ClinicalTrials.gov ID
- NCT03465020
- Acronym / sponsor ID
- ITP0918 / ITP0918
- Conditions
- Idiopathic Thrombocytopenic Purpura
- Keywords
- Idiopathic, Thrombocytopenic, Purpura
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 861 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Collaborators
- Fondazione Progetto Ematologia
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 14 Mar 2018 (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.
The objective of the study is to produce a dynamic picture of the adult ITP natural history and management in Italy by collecting standardized information retrospective and prospective data of patients in active management through a nation-wide registry.
Detailed description
Primary immune thrombocytopenia (ITP) is an acquired autoimmune disorder affecting both children and adults, characterized by a platelet count below 100 x 109/L in the absence of any underlying disease explaining the thrombocytopenia. Clinical manifestations may be absent or include cutaneous mucosal or organ bleeding, resulting in an overall mortality rate of less than 1-2%.
Previously, 'acute ITP' was used to describe a self-limited form of the disease and 'chronic ITP' to describe the disease if it lasted for more than 6 months. In 2009, a new terminology for ITP was agreed upon based on the duration of the disease. The new terms for ITP are: 'newly diagnosed ITP (from diagnosis to 3 months), 'persistent ITP' (3-12 months) and 'chronic ITP' (lasting for more than 12 months) [2].
Chronic primary ITP in adults is slightly more common in women of childbearing age but the sex incidence is similar in patients over 60. The incidence of ITP in adults is around 4 per 100.000 people per year, with a UK prevalence of up to 24 per 100.000 people [4-6]. No more than 2 per 100.000 will require ITP treatment.
Bleeding is highly variable and there is great heterogeneity. Bleeding is most commonly mucocutaneous, involving the skin and subcutaneous tissue (petechiae, ecchymoses, subcutaneous hematomas), the external mucosae (epistaxis, gum bleeding, blood blisters in the mouth), muscles (muscle hematomata) or the various organs and internal mucosae (hematuria, gastrointestinal bleeding, menorrhagia, intracerebral bleeding). Major bleeding is not common if the platelet count is above 30x109/L. Intracranial hemorrhage is rare and is most often seen in older patients who have additional comorbidities and in patients who fail to respond to therapy. The yearly risk of fatal hemorrhage is around 1.6-3.9% in unresponsive patients. This risk varies with age, from 0.4% per year in patients below 40 years old to 13% per year in those over 60. The natural history of ITP with currently available treatments is not well known. Available data are mostly based on the era when rituximab and thrombopoietin-receptor agonists (TPO-RA) were not in use.
There is a lack reliable data on how recent treatments have modified the course of the disease. Bleeding frequency and severity, complications like infections, thrombosis, ITP-related symptoms like fatigue, etc. are also largely unknown as are women's related issues. Similarly, the cost of treatment for a patient with ITP is not available. Safety and efficacy of specific recent treatments have been measured mostly in industry-sponsored studies. Furthermore, most studies did not conform to the International Working Group (IWG) on ITP recommendations concerning terminology, definitions, outcome criteria and assessment of bleeding.
To the investigator's knowledge, an ITP Registry is ongoing in UK and in Australia and registries are being planned in other European countries with a prospective of creating an international network. The only established international registry, the ITP PARC study, is operative since 2004 but covers different aspects of the disease. The few Italian registries are of regional dimension and are not aligned to collect standardized information in a uniform way.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ITP patients | – | Other: ObservationOn active treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All consecutive adult patients (18 years or older) in active treatment for ITP meeting one of the three conditions at their first visit after the enrolment has been opened. In all cases, patients should be enrolled at the first visit during the enrolment period (or at latest within 1 month with data referred back to the first visit).
Key inclusion criteria (3 listed)
- Patients never treated before for whom an ITP treatment is initiated for the first time by the recruiting center
- Patients already treated for whom a new line of ITP treatment is initiated by the recruiting center (the patients could have been treated elsewhere before)
- Patients who, under any ITP treatment at the recruiting center.
Key exclusion criteria (1 listed)
- -Undefined
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 |
|---|---|---|
| ObservationSafety and efficacy outcomes of patients on different treatments | Other | ITP patients |
Primary outcome
Number of adverse events in ITP adult patients
Time frame: After 36 months from study enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Francesco Rodeghiero study chair
Department of Hematology, S. Bortolo Hospital of Vicenza
Marco Ruggeri study director
Department of Hematology, S. Bortolo Hospital, Vicenza
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Thrombocytopenic Purpura, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 26 sites 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paola Fazi (+39 06.70390521, p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events in ITP adult patients (time frame: After 36 months from study enrollment). 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 20 Jul 2022.