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NCT02877706 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
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Completed NCT02868099 - Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP) Phase 3
Completed NCT02556814 - Caffeic Acid Combining High-dose Dexamethasone in Management of ITP Phase 4
Terminated NCT02401061 - PRTX-100-202 Open-Label, Dose Escalation Study in Adult Patients With ITP Phase 1/Phase 2
Completed NCT02351622 - Caffeic Acid Tablets as a Second-line Therapy for ITP Phase 3
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Not yet recruiting NCT05468866 - The Expression of Immune Checkpoint CD28 rs1980422-related Single-nucleotide Polymorphisms in the Primary Immune Thrombocytopenia N/A
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Not yet recruiting NCT05020288 - A Clinical Trial of the Orelabrutinib in the Management of Refractory ITP Phase 2
Withdrawn NCT03965624 - Efficacy and Safety of Ixazomib and Dexamethasone Refractory Autoimmune Cytopenia Phase 2
Not yet recruiting NCT03252457 - Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP Phase 3
Recruiting NCT05937828 - OBS'CEREVANCE: French Cohort of Pediatric Autoimmune Cytopenia
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Completed NCT03164915 - A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP) Phase 3
Recruiting NCT02270801 - Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP) in Pregnancy Phase 3
Completed NCT01933035 - Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias. N/A
Withdrawn NCT01976195 - High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP Phase 2
Recruiting NCT02821572 - Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)