Immune ThrombocytopeniaCARMENNCT02877706
French Registry of Adult Patients With Immune Thrombocytopenia and Autoimmune Hemolytic Anemia
An observational study of Immune Thrombocytopenia and Autoimmune Hemolytic Anemia, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Thrombocytopenia, Autoimmune Hemolytic Anemia
- What is being tested?
- no specific intervention
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Dec 2029
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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).
Who may be able to join
- adult patients (18+ year-old)
- newly diagnosed for ITP/AIHA or initiation of FOSFAMATINIB
Who cannot join
- opposition to data collection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Moulis Guillaume, MD PhD contact
Johanne Germain, PhD contact
France1 site, 1 recruiting
- Recruiting
Service de Médecine Interne
Toulouse, 31000
Moulis Guillaume, MD, PhD, moulis.g@chu-toulouse.fr
About this study
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.
- Being tested
- no specific intervention
- Keywords
- Registry
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Anemia, Hemolytic, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no specific interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Immune thrombocytopenia (ITP) and AIHA
Number of new cases
Measured: Baseline
Natural evolution and events
Disease duration. Description of bleeding, infection, thrombosis events
Measured: Baseline and follow-up
Secondary outcomes (8)
Response
platelet count >30 G/L and no bleeding
Measured: 15 years
Complete rate
platelet count >30 G/L and no bleeding
Measured: 15 years
Treatment lines
% of patients with each treatment by line of treatments
Measured: 15 years
Adverse drug reactions
% of patients with adverse drug reaction reported by investigators
Measured: 15 years
Bleeding
% of patients with bleeding during follow-up
Measured: 15 years
Rescue treatment
% of patients with any treatment added during the exposure of ongoing treatment
Measured: 15 years
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
Measured: 15 years
Events
% of patients with other events of interest like cancer, death, infection, thrombosis
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startJun 2013
- Primary completionDec 2026 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moulis Guillaume, MD PhD, Principal investigator, University Hopsital Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877706
- Sponsor's protocol ID
- RC31/12/0386
- Acronym
- CARMEN
- Status last verified
- Dec 2025
- First submitted
- 2 Jul 2016
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Larue M, Moulis G, Rueter M, Audia S, Comont T, Terriou L, Viallard JF, Pan-Petesch B, Royer B, Bonnotte B, Galicier L, Lambotte O, Lefrere F, Cheze S, Ebbo M, Duong TA, Boutin E, Languille L, Mahevas M, Godeau B, Canoui-Poitrine F, Michel M. Efficacy and safety of dapsone in adult primary immune thrombocytopenia. Blood Adv. 2025 Apr 22;9(8):1976-1983. doi: 10.1182/bloodadvances.2024014939.
PubMed 39874521
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Registry of Adult Patients With Immune Thrombocytopenia and Autoimmune Hemolytic Anemia
- ClinicalTrials.gov ID
- NCT02877706
- Acronym / sponsor ID
- CARMEN / RC31/12/0386
- Keywords
- Registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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).
Key inclusion criteria (2 listed)
- adult patients (18+ year-old)
- newly diagnosed for ITP/AIHA or initiation of FOSFAMATINIB
Key exclusion criteria (1 listed)
- opposition to data collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no specific intervention | Other | – |
Primary outcome
Incidence of Immune thrombocytopenia (ITP) and AIHA
Time frame: Baseline
Number of new cases
Natural evolution and events
Time frame: Baseline and follow-up
Disease duration. Description of bleeding, infection, thrombosis events
8 secondary outcomes
Response
Time frame: 15 years
Complete rate
Time frame: 15 years
Treatment lines
Time frame: 15 years
Adverse drug reactions
Time frame: 15 years
Bleeding
Time frame: 15 years
Rescue treatment
Time frame: 15 years
Adherence to ITP management guidelines.
Time frame: 15 years
Events
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Derived from this study: PubMed 39874521Larue M, Moulis G, Rueter M, Audia S, Comont T, Terriou L, Viallard JF, Pan-Petesch B, Royer B, Bonnotte B, Galicier L, Lambotte O, Lefrere F, Cheze S, Ebbo M, Duong TA, Boutin E, Languille L, Mahevas M, Godeau B, Canoui-Poitrine F, Michel M. Efficacy and safety of dapsone in adult primary immune thrombocytopenia. Blood Adv. 2025 Apr 22;9(8):1976-1983. doi: 10.1182/bloodadvances.2024014939.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Moulis Guillaume, MD PhD contact
Johanne Germain, PhD contact
Moulis Guillaume, MD PhD principal investigator
University Hopsital Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Thrombocytopenia and Autoimmune Hemolytic Anemia, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moulis Guillaume, MD PhD (moulis.g@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Immune thrombocytopenia (ITP) and AIHA (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02877706, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.