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Recruiting NCT02877706

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

Observational Immune Thrombocytopenia Autoimmune Hemolytic Anemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: no specific intervention.
Who it may be relevant to
Registry conditions: Immune Thrombocytopenia, Autoimmune Hemolytic Anemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Other no specific intervention

Primary outcome measures

  • Incidence of Immune thrombocytopenia (ITP) and AIHA [Time frame: Baseline]
  • Natural evolution and events [Time frame: Baseline and follow-up]
Secondary outcome measures (8)
  • Response [Time frame: 15 years]
  • Complete rate [Time frame: 15 years]
  • Treatment lines [Time frame: 15 years]
  • Adverse drug reactions [Time frame: 15 years]
  • Bleeding [Time frame: 15 years]
  • Rescue treatment [Time frame: 15 years]
  • Adherence to ITP management guidelines. [Time frame: 15 years]
  • Events [Time frame: 15 years]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

\- opposition to data collection

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Service de Médecine Interne — Toulouse

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. PMID 39874521

Identifiers

NCT: NCT02877706 · RC31/12/0386

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗