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

• Sponsor: University Hospital, Toulouse (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02877706
• Collaborator: (none)
• Enrollment: 1,500
• Location: 1
• Duration (Months): 168
• Patients Per Site Per Month: 8.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Immune Thrombocytopenia; Autoimmune Hemolytic Anemia	Other: no specific intervention

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 1500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: French Registry of Adult Patients With Immune Thrombocytopenia and Autoimmune Hemolytic Anemia
• Study Start Date: Jun 1, 2013
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2027

Outcome Measures

Primary Outcome Measures

1. Incidence of Immune thrombocytopenia (ITP) and AIHA [Baseline]

   Number of new cases

2. Natural evolution and events [Baseline and follow-up]

   Disease duration. Description of bleeding, infection, thrombosis events

Secondary Outcome Measures

1. Response [15 years]

   platelet count >30 G/L and no bleeding

2. Complete rate [15 years]

   platelet count >30 G/L and no bleeding

3. Treatment lines [15 years]

   % of patients with each treatment by line of treatments

4. Adverse drug reactions [15 years]

   % of patients with adverse drug reaction reported by investigators

5. Bleeding [15 years]

   % of patients with bleeding during follow-up

6. Rescue treatment [15 years]

   % of patients with any treatment added during the exposure of ongoing treatment

7. 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

8. Events [15 years]

   % of patients with other events of interest like cancer, death, infection, thrombosis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• adult patients (18+ year-old)

• newly diagnosed for ITP/AIHA or initiation of FOSFAMATINIB

Exclusion criteria:

• opposition to data collection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service de Médecine Interne	Toulouse		France	31000

Sponsors and Collaborators

• University Hospital, Toulouse

Investigators

• Principal Investigator: Moulis Guillaume, MD PhD, University Hopsital Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Toulouse
• ClinicalTrials.gov Identifier: NCT02877706
• Other Study ID Numbers: RC31/12/0386
• First Posted: Aug 24, 2016
• Last Update Posted: Jan 27, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Toulouse: Registry
• Additional relevant MeSH terms: Anemia; Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic; Anemia, Hemolytic; Anemia, Hemolytic, Autoimmune; Hemolysis

Study Results

No Results Posted as of Jan 27, 2022