ClinicalTrials.gov record NCT02877706
French Registry of Adult Patients With Immune Thrombocytopenia and Autoimmune Hemolytic Anemia
French Registry of Adult Patients With Immune Thrombocytopenia and Autoimmune Hemolytic Anemia
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.
This is a prospective observational registry that records adult patients with newly diagnosed immune thrombocytopenia (ITP) or autoimmune hemolytic anemia (AIHA), or adults starting FOSFAMATINIB. The study collects clinical features, treatments used, outcomes, and adverse events, and follows participants over the long term (up to 15 years).
What it is studying. The study aims to describe disease features and incidence, track natural history and events (bleeding, infection, thrombosis), record treatments and adverse reactions, and assess adherence to ITP/AIHA management guidelines.
What the researchers hope to learn. Describe clinical features and incidence of ITP and AIHA; document natural evolution and events; report response rates and complete rates; record lines of treatment and adverse drug reactions; measure bleeding, rescue treatments, adherence to management guidelines, and other events (cancer, death, infection, thrombosis) over 15 years.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
CARMEN is a national, real-world clinical registry of all adult patients with incident diagnosis of Immune thrombocytopenia (ITP) or Autoimmune Hemolytic anemia (AIHA) patients in France. It is aimed at describing ITP and AIHA clinical features, assessing the real-world risk-benefit ratio of treatments and adherence to guidelines for ITP and AIHA management.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- no specific intervention
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- adult patients (18+ year-old)
- newly diagnosed for ITP/AIHA or initiation of FOSFAMATINIB
Exclusion criteria
- opposition to data collection
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
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 allow their clinical information to be entered into a registry at enrollment (baseline) and during follow-up visits. The study will record diagnosis details, treatments received, laboratory results and events of interest (for example bleeding, infections, thrombosis, and adverse drug reactions); the registry does not assign a study treatment. Follow-up and data collection can continue for up to 15 years according to the record.
How the study is structured. A prospective observational registry (cohort). There is no study-assigned treatment. Investigators record medical information at enrollment (baseline) and during follow-up visits for up to 15 years.
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 France. 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 autoimmune hemolytic anemia
Important dates
- Study start
- June 2013
- Primary completion
- December 2026 (estimated)
- Study completion
- December 2029 (estimated)
- Target enrollment
- 1500 participants (estimated)
- Last updated on registry
- Dec 31, 2025
- 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
- University Hospital, Toulouse
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.
- Moulis Guillaume, MD PhD ✉ moulis.g@chu-toulouse.fr
- Johanne Germain, PhD ✉ johanne.germain@inserm.fr
Participating sites (1)
- Service de Médecine InterneRecruiting
Toulouse, 31000 · France
- Moulis Guillaume, MD, PhD · moulis.g@chu-toulouse.fr
Terms used on this page · explanations by MedicalUpdates.ai
- registry
- An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
- 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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