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RecruitingNCT02877706CARMENUpdated Dec 31, 2025

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

An observational study in Immune Thrombocytopenia and Autoimmune Hemolytic Anemia, sponsored by University Hospital, Toulouse. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-31.

Sponsored by University Hospital, Toulouse · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Immune Thrombocytopenia
  • Autoimmune Hemolytic Anemia

Keywords

  • Registry
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In context

Purpura, Thrombocytopenic, Idiopathic

517 studies on the registry are indexed under Purpura, Thrombocytopenic, Idiopathic; 161 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 131 across 108 observational studies indexed under Purpura, Thrombocytopenic, Idiopathic.

Browse Purpura, Thrombocytopenic, Idiopathic studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Multicentric adult ITP and AIHA case recording in France, selected in centers of the French Referral Autoimmune Cytopenia Network. Both secondary and tertiary (referral) centers are participating (N=44).

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

- opposition to data collection

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Target follow-up
15 Years
Patient registry
Yes

Interventions

  • Otherno specific intervention
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What researchers measure

Primary outcomes

  1. Incidence of Immune thrombocytopenia (ITP) and AIHA

    Number of new cases

    Time frame: Baseline

  2. Natural evolution and events

    Disease duration. Description of bleeding, infection, thrombosis events

    Time frame: Baseline and follow-up

Secondary outcomes

  1. Response

    platelet count \>30 G/L and no bleeding

    Time frame: 15 years

  2. Complete rate

    platelet count \>30 G/L and no bleeding

    Time frame: 15 years

  3. Treatment lines

    % of patients with each treatment by line of treatments

    Time frame: 15 years

  4. Adverse drug reactions

    % of patients with adverse drug reaction reported by investigators

    Time frame: 15 years

  5. Bleeding

    % of patients with bleeding during follow-up

    Time frame: 15 years

  6. Rescue treatment

    % of patients with any treatment added during the exposure of ongoing treatment

    Time frame: 15 years

  7. Adherence to ITP management guidelines.

    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

    Time frame: 15 years

  8. Events

    % of patients with other events of interest like cancer, death, infection, thrombosis

    Time frame: 15 years

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Study locations

1 of 1 sites recruiting
  • Service de Médecine Interne
    Toulouse, 31000, France
    Recruiting
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References and documents

Publications

  • Larue M, Moulis G, Rueter M, Audia S, Comont T, Terriou L, Viallard JF, Pan-Petesch B, Royer B, Bonnotte B, Galicier L, Lambotte O, Lefrere F, Cheze S, Ebbo M, Duong TA, Boutin E, Languille L, Mahevas M, Godeau B, Canoui-Poitrine F, Michel M. Efficacy and safety of dapsone in adult primary immune thrombocytopenia. Blood Adv. 2025 Apr 22;9(8):1976-1983. doi: 10.1182/bloodadvances.2024014939. PubMed 39874521 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02877706
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Aug 24, 2016
Start date
Jun 2013
Primary completion
Dec 2026 (estimated)
Completion
Dec 2029 (estimated)
Last update
Dec 31, 2025

Study contacts

Moulis Guillaume, MD PhD
Contact
moulis.g@chu-toulouse.fr
Johanne Germain, PhD
Contact
johanne.germain@inserm.fr
Moulis Guillaume, MD PhD
principal investigator · University Hopsital Toulouse

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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