French Registry of Adult Patients With Immune Thrombocytopenia and Autoimmune Hemolytic Anemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adult patients (18+ year-old)
newly diagnosed for ITP/AIHA or initiation of FOSFAMATINIB
Disqualifiers
None
Trial 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
no specific intervention
Other intervention
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Incidence of Immune thrombocytopenia (ITP) and AIHA
Number of new cases
Time frame
Baseline2
Natural evolution and events
Disease duration. Description of bleeding, infection, thrombosis events
Time frame
Baseline and follow-upSecondary outcomes
1
Response
platelet count \>30 G/L and no bleeding
Time frame
15 years2
Complete rate
platelet count \>30 G/L and no bleeding
Time frame
15 years3
Treatment lines
% of patients with each treatment by line of treatments
Time frame
15 years4
Adverse drug reactions
% of patients with adverse drug reaction reported by investigators
Time frame
15 yearsSponsors and contacts
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Source ClinicalTrials.gov