Chronic Immune ThrombocytopeniaNCT06665308
Cognitive Status, Fatigue and Inflammation in Patients With Immune Thrombocytopenia (ITP)
An observational study of Chronic Immune Thrombocytopenia and Primary Immune Thrombocytopenia, run by Sanofi at 4 sites in 2 countries.
Trial summary
This is a multi-center, hospital based, cross-sectional study based on data from patient medical records, including laboratory results. The study will include adult patients with chronic (> 1 year duration) primary Immune Thrombocytopenia (ITP) only. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Immune Thrombocytopenia, Primary Immune Thrombocytopenia, Adult Immune Thrombocytopenia
- How many people
- 97 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 13 Jan 2025to 26 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The source population for this study will be patients treated for primary chronic Immune Thrombocytopenia at one of the four study centers in two countries (3 centers in the USA, 1 center in the UK).
Who may be able to join
- Patient diagnosed with chronic (ITP with > 1 year duration) primary ITP living in the USA or the UK:
- On ITP pharmacologic treatment, , including on-demand treatment strategy, regardless of last platelet count (below or above 100 x 10^9 counts/L);
- Patients with their most recent platelet count >50 x 109 counts/L) and without any ITP-specific treatment for 1 year or less.
- Adult patient who are 18 years or older at index date
- Patient who has received at least one initial first line ITP therapy (CS/ IVIg/ANTI d) with initial response as of index date and indicated by one of the following:
- Platelet count ≥ 50 x 10^9 counts /L; OR
Show all 10Show fewer
- Platelet count ≥ 30 x 10^9 counts /L with at least a two-fold increase from baseline within 1 month since start of treatment, as per ASH 2019 guidelines; OR
- A medical record of initial response as determined by clinical judgement, considering documented platelet count along with overall patient condition and relevant medical factors.
- Patients whose medical history related to the study objectives are available from the site covering 12 months prior to index date.
- Patient provided informed consent to participate in the study.
Who cannot join
- Secondary ITP.
- Patients with their most recent platelet count >50 x 10^9 counts/L and without any ITP-specific treatment for more than 1 year.
- Patients with recent or active infection recorded 14 days or less before index date; patients with uncontrolled chronic infections or who were recently diagnosed with a chronic infection (≤14 days of index date).
- Patients with vaccination in 28 days before index date.
- Patients treated with rilzabrutinib on or before index date.
- Patients who participated in an interventional clinical trial for any investigational drug in the 180 days prior to index date.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Massachusetts General Hospital- Site Number : 8400001
Boston, Massachusetts, 02114
USC Norris Comprehensive Cancer Center- Site Number : 8400002
Los Angeles, California, 90033
University of Washington-Fred Hutchinson Cancer Center_Site Number: 8400003
Seattle, Washington, 98109
United Kingdom1 site
Investigational Site Number: 8260001
London, London, City of, W12 0HS
About this study
Official title: Cognitive Status, Fatigue, and Inflammation in Patients With Immune Thrombocytopenic Purpura (ITP)
This is a multi-center, hospital based, cross-sectional study based on data from patient medical records, including laboratory results. The study will include adult patients with chronic (> 1 year duration) primary Immune Thrombocytopenia (ITP) only. Patients will be identified based on a laboratory confirmed diagnosis of ITP in the medical records, where there is also a physician-confirmed diagnosis of primary ITP. If patients consent to take part in the study, a routine clinical visit will also serve as the study visit. Patients who do not have a routine visit scheduled during the study period but who would otherwise be eligible may be contacted by the site. In such cases, clinicians may use their discretion to schedule a visit specifically for study purposes.
All study participants will have a routine blood test as part of their standard clinical care at the study visit, and this same procedure will be used to collect supplementary blood samples to assess a variety of biomarkers.
Data will be collected using a combination of chart review, clinical outcome assessment administration, and laboratory results through blood tests.
- Conditions
- Chronic Immune Thrombocytopenia, Primary Immune Thrombocytopenia, Adult Immune Thrombocytopenia
- Being tested
- No intervention
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention will be administered to study participants. Data will be collected using a combination of chart review, clinical outcome assessment administration, and laboratory results through blood tests.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of impaired cognitive status among adult Immune Thrombocytopenia patients
Impaired cognitive status is defined as a CBB (CogState Brief Battery) z-score of -1 or less on at least one of 2 composite domains (attention/psychomotor composite and memory/learning composite domains).
The CBB is a computerized outcome measure of cognitive function in human subjects aged 6 to 99 years and has been previously used in ITP. The CBB test for psychomotor function, attention, visual learning and working memory.
Measured: Day 1 (Index date)
Secondary outcomes (10)
Age, sex, ethnicity, educational attainment
Measured: Day 1 (Index date)
Smoking, alcohol, marijuana, cocaine use
Measured: Day 1 (Index date)
Comorbidities at index categorical
Measured: Day 1 (Index date)
Current medications
ITP-specific treatments, antiplatelet,anticoagulant, psychiatric and pain medications
Measured: Day 1 (Index date)
ITP-PAQ
A validated, disease-specifictool to measure health-related quality of life HRQoL in adult ITP patients
Measured: Day 1 (Index date)
ITP Bleeding Scale (IBLS)
Measured: Day 1 (Index date)
Medical history
Family history of dementia, family history of cognitive impairment, ITP medication and treatment history, age of ITP diagnosis, duration of ITP, history of clinically relevant or severe bleeding complications, history of thromboembolism complications, history of brain injury or neurological sequalae, history of COVID-19, brain imaging results, platelet counts results
Measured: Day 1 (Index date)
Laboratory characteristics
Complete Blood Count
Measured: Day 1 (Index date)
Assessment of key inflammatory biomarkers
Transferrin, Ferritin, Iron, Prothrombin fragment, Fibrinogen, D dimer, Interleukin (IL)-1 beta, IL-6, IL-10, IL-18, TNF alpha, Gamma Interferon, high-sensitivity C-reactive protein (hsCRP), MCP1, NETosis markers (cell-free deoxyribonucleic acid (DNA), neutrophil elastase (NE), myeloperoxidase (MPO)), antinuclear antibodies (ANA), Lupus anticoagulant, Anticardiolipin antibodies (ACA), thrombopoietin level, soluble P-selectin, L-selectin, ICAM-1; whole blood RNA sequencing (transcriptome), C1q, sC5b-9
Measured: Day 1 (Index date)
FACIT (Functional Assessment of Chronic Illness Therapy) - Fatigue score
The FACIT-Fatigue is a 13-item tool that measures self-reported fatigue and its impact on daily life. Each question is rated by the participant on a Likert-like scale of 0 ('not at all') to 4 ('very much'). A higher FACIT-Fatigue score represents greater quality of life (QoL).
Measured: Day 1 (Index date)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start13 Jan 2025
- Primary completion26 Nov 2025
- Study completion26 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Immune ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Cross-sectional
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665308
- Sponsor's protocol ID
- OBS18052
- Other IDs
- U1111-1299-2041
- Status last verified
- Jan 2026
- First submitted
- 10 Oct 2024
- Last updated
- 26 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Status, Fatigue, and Inflammation in Patients With Immune Thrombocytopenic Purpura (ITP)
- ClinicalTrials.gov ID
- NCT06665308
- Acronym / sponsor ID
- OBS18052
- Conditions
- Chronic Immune Thrombocytopenia, Primary Immune Thrombocytopenia, Adult Immune Thrombocytopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 30 Oct 2024 (actual)
- 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.
This is a multi-center, hospital based, cross-sectional study based on data from patient medical records, including laboratory results. The study will include adult patients with chronic (> 1 year duration) primary Immune Thrombocytopenia (ITP) only. Patients will be identified based on a laboratory confirmed diagnosis of ITP in the medical records, where there is also a physician-confirmed diagnosis of primary ITP. If patients consent to take part in the study, a routine clinical visit will also serve as the study visit. Patients who do not have a routine visit scheduled during the study period but who would otherwise be eligible may be contacted by the site. In such cases, clinicians may use their discretion to schedule a visit specifically for study purposes.
All study participants will have a routine blood test as part of their standard clinical care at the study visit, and this same procedure will be used to collect supplementary blood samples to assess a variety of biomarkers.
Data will be collected using a combination of chart review, clinical outcome assessment administration, and laboratory results through blood tests.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The source population for this study will be patients treated for primary chronic Immune Thrombocytopenia at one of the four study centers in two countries (3 centers in the USA, 1 center in the UK).
Key inclusion criteria (10 listed)
- Patient diagnosed with chronic (ITP with > 1 year duration) primary ITP living in the USA or the UK:
- Adult patient who are 18 years or older at index date
- Patient who has received at least one initial first line ITP therapy (CS/ IVIg/ANTI d) with initial response as of index date and indicated by one of the following:
- Patients whose medical history related to the study objectives are available from the site covering 12 months prior to index date.
- Patient provided informed consent to participate in the study.
Key exclusion criteria (6 listed)
- Secondary ITP.
- Patients with their most recent platelet count >50 x 10^9 counts/L and without any ITP-specific treatment for more than 1 year.
- Patients with recent or active infection recorded 14 days or less before index date; patients with uncontrolled chronic infections or who were recently diagnosed with a chronic infection (≤14 days of index date).
- Patients with vaccination in 28 days before index date.
- Patients treated with rilzabrutinib on or before index date.
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 interventionNo intervention will be administered to study participants. Data will be collected using a combination of chart review, clinical outcome assessment administration, and laboratory results through blood tests. | Other | – |
Primary outcome
Prevalence of impaired cognitive status among adult Immune Thrombocytopenia patients
Time frame: Day 1 (Index date)
Impaired cognitive status is defined as a CBB (CogState Brief Battery) z-score of -1 or less on at least one of 2 composite domains (attention/psychomotor composite and memory/learning composite domains). The CBB is a computerized outcome measure of cognitive function in human subjects aged 6 to 99 years and has been previously used in ITP. The CBB test for psychomotor function, attention, visual learning and working memory.
10 secondary outcomes
Age, sex, ethnicity, educational attainment
Time frame: Day 1 (Index date)
Smoking, alcohol, marijuana, cocaine use
Time frame: Day 1 (Index date)
Comorbidities at index categorical
Time frame: Day 1 (Index date)
Current medications
Time frame: Day 1 (Index date)
ITP-PAQ
Time frame: Day 1 (Index date)
ITP Bleeding Scale (IBLS)
Time frame: Day 1 (Index date)
Medical history
Time frame: Day 1 (Index date)
Laboratory characteristics
Time frame: Day 1 (Index date)
Assessment of key inflammatory biomarkers
Time frame: Day 1 (Index date)
FACIT (Functional Assessment of Chronic Illness Therapy) - Fatigue score
Time frame: Day 1 (Index date)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Immune Thrombocytopenia and Primary Immune Thrombocytopenia, run by Sanofi at 4 sites in 2 countries.
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 10 inclusion and 6 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: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of impaired cognitive status among adult Immune Thrombocytopenia patients (time frame: Day 1 (Index date)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2026.