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

Recruiting

• Conditions: Immune Thrombocytopenia; Autoimmune Hemolytic Anemia

• Registration Number: NCT02877706
• Lead Sponsor: University Hospital, Toulouse

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2016-07-02
• Study First Submitted QC: 2016-08-18
• Study First Posted: 2016-08-24
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-27
• Primary Completion: 2025-06
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

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

Exclusion criteria:

• opposition to data collection

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Adverse drug reactions	15 years	% of patients with adverse drug reaction reported by investigators
Complete rate	15 years	platelet count \>30 G/L and no bleeding
Bleeding	15 years	% of patients with bleeding during follow-up
Response	15 years	platelet count \>30 G/L and no bleeding
Treatment lines	15 years	% of patients with each treatment by line of treatments
Rescue treatment	15 years	% of patients with any treatment added during the exposure of ongoing treatment
Events	15 years	% of patients with other events of interest like cancer, death, infection, thrombosis
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

Trial Locations

Locations (1)

Service de Médecine Interne; 🇫🇷 Toulouse, France