CompletedPhase 3

Initial Hemato-immunological Profile on the Evolution of Immunological Thrombopenic Purpura.

France70 participantsStarted 2011-04-12

Plain-language summary

This study aims to determine the hemato-immunological parameters predictive of the evolution of a Immune thrombocytopenic purpura (ITP) towards chronicity, and to identify possible differences between the child and the adult.

Who can participate

Age range

2 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Minor patients aged 2 to 18 recruited at the Children's Hospital, in the service of Prof. Y. PEREL, Dr. N. ALADJIDI, CEREVANCE, * Adult patients (\> 18 years old) recruited at the Haut-Lévêque hospital, Pr JL PELLEGRIN, Pr JF VIALLARD, GECAI, * Patient with acute Immune thrombocytopenic purpura, seen at initial diagnosis or within 8 days (defined as thrombocytopenia \<100 G / L, after an infectious cause, drug or related to autoimmune disease, hematological malignancy or deficit Immune have been eliminated, Rodeghiero criteria, 2009). * Patient who received immunoglobulins more than 4 weeks before inclusion * Written consent given by the patient, if he is of age, or by the person (s) having parental authority * Patient affiliated or beneficiary of a social security scheme Exclusion Criteria: * Patient who has received specific treatment from an Immune thrombocytopenic purpura * Patient with secondary Immune thrombocytopenic purpura (hematological malignancy, autoimmune disease, immunodeficiency, pregnancy) * Patient placed under the protection of justice

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial is completed and was measuring complete remission in immune thrombocytopenic purpura, has the data been published yet, and if so, what did it show about which patients were most likely to achieve complete remission?
2This trial looked at the initial blood and immune system profile — does that mean it was trying to predict which ITP patients would do well versus which ones might have a harder course, and could that kind of profiling help guide my own treatment decisions?
3Since this was a Phase 3 study focusing on ITP, how does the information it gathered about hemato-immunological profiles compare to what is already used in standard care to decide between watchful waiting, steroids, or other treatments for my situation?
4The trial tracked whether patients reached complete remission — how is complete remission defined in ITP, and what does it mean practically for someone in my position if that threshold isn't reached?
5Given that this study is completed, would it make sense to ask about enrolling in a similar or follow-up study, or is the evidence from trials like this one already shaping the standard treatment approach my care team would recommend?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Complete remission yes/no

Timeframe: At 12 months of initial diagnosis

Trial details

NCT IDNCT04070599

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-03-05

View on ClinicalTrials.gov More Immune Thrombocytopenic Purpura trials

Who can participate

Age range

2 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.