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NCT Number: NCT02877706

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

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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Key information

Conditions

Immune Thrombocytopenia Anemia Anemia, Hemolytic Anemia, Hemolytic, Autoimmune Autoimmune Diseases Autoimmune Hemolytic Anemia Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Médecine Interne

Toulouse, 31000, France

Location status: Recruiting

Location contact

Moulis Guillaume, MD, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • opposition to data collection

Treatment and study plan

No specific intervention

Other

Primary outcomes

  1. Incidence of Immune thrombocytopenia (ITP) and AIHA

    Time frame: Baseline

    Number of new cases

  2. Natural evolution and events

    Time frame: Baseline and follow-up

    Disease duration. Description of bleeding, infection, thrombosis events

Secondary outcomes

  1. Response

    Time frame: 15 years

    platelet count >30 G/L and no bleeding

  2. Complete rate

    Time frame: 15 years

    platelet count >30 G/L and no bleeding

  3. Treatment lines

    Time frame: 15 years

    % of patients with each treatment by line of treatments

  4. Adverse drug reactions

    Time frame: 15 years

    % of patients with adverse drug reaction reported by investigators

  5. Bleeding

    Time frame: 15 years

    % of patients with bleeding during follow-up

  6. Rescue treatment

    Time frame: 15 years

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

  7. Adherence to ITP management guidelines.

    Time frame: 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

  8. Events

    Time frame: 15 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Johanne Germain, PhD

CONTACT

[email protected]

Moulis Guillaume, MD PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: CARMEN

Important dates

Study start
2013
Primary completion
2026
Study completion
2029
First posted
Aug 24, 2016
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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