French Registry of Adult Patients With Immune Thrombocytopenia and Autoimmune Hemolytic Anemia

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02877706

Acronym

CARMEN

Enrollment

1500

Registered

2016-08-24

Start date

2013-06-30

Completion date

2029-12-31

Last updated

2025-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Hemolytic Anemia, Immune Thrombocytopenia

Keywords

Registry

Brief summary

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

OTHERno specific intervention

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* adult patients (18+ year-old) * newly diagnosed for ITP/AIHA or initiation of FOSFAMATINIB

Exclusion criteria

\- opposition to data collection

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Immune thrombocytopenia (ITP) and AIHA	Baseline	Number of new cases
Natural evolution and events	Baseline and follow-up	Disease duration. Description of bleeding, infection, thrombosis events

Secondary

Measure	Time frame	Description
Complete rate	15 years	platelet count \>30 G/L and no bleeding
Adverse drug reactions	15 years	% of patients with adverse drug reaction reported by investigators
Bleeding	15 years	% of patients with bleeding during follow-up
Treatment lines	15 years	% of patients with each treatment by line of treatments
Adherence to ITP management guidelines.	15 years	Percentage of patients who benefitted from the recommended examinations to detect secondary ITP and the percentage of patients who benefitted from the recommended first-line and second line treatments
Events	15 years	% of patients with other events of interest like cancer, death, infection, thrombosis
Rescue treatment	15 years	% of patients with any treatment added during the exposure of ongoing treatment
Response	15 years	platelet count \>30 G/L and no bleeding

Countries

France

Contacts

Primary ContactMoulis Guillaume, MD PhD

moulis.g@chu-toulouse.fr

Backup ContactJohanne Germain, PhD

johanne.germain@inserm.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026