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

Immune Thrombocytopenia Clinical Trial

— CARMEN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02877706
• Other study ID #: RC31/12/0386
• Status: Recruiting
• Start date: June 2013
• Est. completion date: June 2029

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: Moulis Guillaume, MD PhD
• Email: moulis.g[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: June 2029
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients (18+ year-old)

• newly diagnosed for ITP/AIHA or initiation of FOSFAMATINIB

Exclusion criteria:

• opposition to data collection

Related Conditions & MeSH terms

• Anemia
• Anemia, Hemolytic
• Anemia, Hemolytic, Autoimmune
• Autoimmune Hemolytic Anemia
• Hemolysis
• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Other:
• no specific intervention

Locations

Country	Name	City	State
France	Service de Médecine Interne	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Immune thrombocytopenia (ITP) and AIHA	Number of new cases	Baseline
Primary	Natural evolution and events	Disease duration. Description of bleeding, infection, thrombosis events	Baseline and follow-up
Secondary	Response	platelet count >30 G/L and no bleeding	15 years
Secondary	Complete rate	platelet count >30 G/L and no bleeding	15 years
Secondary	Treatment lines	% of patients with each treatment by line of treatments	15 years
Secondary	Adverse drug reactions	% of patients with adverse drug reaction reported by investigators	15 years
Secondary	Bleeding	% of patients with bleeding during follow-up	15 years
Secondary	Rescue treatment	% of patients with any treatment added during the exposure of ongoing treatment	15 years
Secondary	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	15 years
Secondary	Events	% of patients with other events of interest like cancer, death, infection, thrombosis	15 years