NCT06665308|Completed
Cognitive Status, Fatigue and Inflammation in Patients With Immune Thrombocytopenia (ITP)
Cognitive Status, Fatigue, and Inflammation in Patients With Immune Thrombocytopenic Purpura (ITP)
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Cognitive Status, Fatigue, and Inflammation in Patients With Immune Thrombocytopenic Purpura (ITP)
Sponsor study identifier
Secondary identifiers
OTHER · ICTRP
observational
97
2 countries
4
Study Start
January 13, 2025
Actual (reported)Primary Completion
November 26, 2025
Actual (reported)Study Completion
November 26, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 26, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 10, 2024
Actual (reported)October 30, 2024
Actual (reported)January 13, 2025
Actual (reported)November 26, 2025
Actual (reported)November 26, 2025
Actual (reported)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.
Day 1 (Index date)
Age, sex, ethnicity, educational attainment
Day 1 (Index date)
Smoking, alcohol, marijuana, cocaine use
Day 1 (Index date)
Comorbidities at index categorical
Day 1 (Index date)
Current medications
Day 1 (Index date)
ITP-PAQ
Day 1 (Index date)
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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).
USC Norris Comprehensive Cancer Center- Site Number : 8400002
Los Angeles, California, 90033, United States
Massachusetts General Hospital- Site Number : 8400001
Boston, Massachusetts, 02114, United States
University of Washington-Fred Hutchinson Cancer Center_Site Number: 8400003
Seattle, Washington, 98109, United States
Investigational Site Number: 8260001
London, London, City of, W12 0HS, United Kingdom
97 participants (actual enrollment reported by the registry).
First Submitted
October 10, 2024
First Posted
October 30, 2024
Study Start
January 13, 2025
Actual (reported)A Study to Check Liver Health in Boys With XLMTM, a Serious Genetic Muscle Condition
Contact the study team to confirm eligibility.
Primary Completion
November 26, 2025
Actual (reported)Study Completion
November 26, 2025
Actual (reported)Last Updated
January 26, 2026
Record last verified: 2026-01
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
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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