NCT03465020

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
861

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

26 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

4.7 years

First QC Date

March 8, 2018

Last Update Submit

July 19, 2022

Conditions

Keywords

IdiopathicThrombocytopenicPurpura

Outcome Measures

Primary Outcomes (1)

  • Number of adverse events in ITP adult patients

    After 36 months from study enrollment

Study Arms (1)

ITP patients

On active treatment

Other: Observation

Interventions

Safety and efficacy outcomes of patients on different treatments

ITP patients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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).

You may qualify if:

  • 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.

You may not qualify if:

  • Undefined

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Sc Ematologia E Centro Trapianti Midollo Osseo

Parma, SC, Italy

RECRUITING

Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica

Ancona, Italy

RECRUITING

Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto

Bari, Italy

RECRUITING

Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia

Bologna, Italy

RECRUITING

Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo

Cagliari, Italy

RECRUITING

Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania

Capranica, Italy

RECRUITING

Arnas Garibaldi, Po Garibaldi-Nesima - Catania - Uoc Ematologia

Catania, Italy

RECRUITING

Aou Careggi - Firenze - Sod Ematologia

Florence, Italy

RECRUITING

Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia

Milan, Italy

RECRUITING

Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora

Milan, Italy

RECRUITING

Asst Di Monza, Ospedale S. Eugenio - Uo Ematologia E Cta

Monza, Italy

RECRUITING

Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo

Napoli, Italy

RECRUITING

Aou Federico Ii - Napoli - Uoc Ematologia

Napoli, Italy

RECRUITING

Aou Maggiore Della Carita' Di Novara - Scdu Ematologia

Novara, Italy

RECRUITING

Aou Policlinico P. Giaccone - Palermo - Uo Ematologia

Palermo, Italy

RECRUITING

Ospedale S.M. della Misericordia - STROKE UNIT

Perugia, Italy

RECRUITING

Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti

Piacenza, Italy

RECRUITING

Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia

Reggio Emilia, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica

Roma, Italy

RECRUITING

Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia

San Giovanni Rotondo, Italy

RECRUITING

Asl Taranto, Ospedale Ss. Annunziata - Uoc Ematologia

Taranto, Italy

RECRUITING

Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino

Torino, Italy

RECRUITING

Ente Ecclesiastico Cardinale G. Panico - Tricase - Uo Ematologia

Tricase, Italy

RECRUITING

Azienda Sanitaria Universitaria Integrata Di Trieste - Sc Ematologia

Trieste, Italy

RECRUITING

Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica

Udine, Italy

RECRUITING

Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia

Vicenza, Italy

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, IdiopathicPurpura

Interventions

Observation

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Francesco Rodeghiero

    Department of Hematology, S. Bortolo Hospital of Vicenza

    STUDY CHAIR
  • Marco Ruggeri

    Department of Hematology, S. Bortolo Hospital, Vicenza

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2018

First Posted

March 14, 2018

Study Start

October 15, 2018

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

July 20, 2022

Record last verified: 2022-07

Locations