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NCT06665308 · ClinicalTrials.gov registry record

Cognitive Status, Fatigue and Inflammation in Patients With Immune Thrombocytopenia (ITP)

A clinical trial, sponsored by Sanofi.

Completed
Registry status
97
Enrollment target

NCT06665308: Completed study, sponsored by Sanofi.

NCT06665308 is a clinical trial that has completed, run by Sanofi. The registered enrollment target is 97 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06665308 has completed, sponsored by Sanofi.

COMPLETED
Registry status
97 participants
Enrollment target

Study 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. 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.

Primary Outcome

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.

Interventions

  • OTHER No intervention

Trial Details

FieldValue
Enrollment Target 97 participants
Start Date 2025-01-13
Est. Completion 2025-11-26
Sanofi

713 total trials

What the finished NCT06665308 record still lists

NCT06665308 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 97 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which No intervention is the first listed.

NCT06665308 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06665308 about?

NCT06665308 is a clinical study titled "Cognitive Status, Fatigue and Inflammation in Patients With Immune Thrombocytopenia (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 laborator...

What is the current status of trial NCT06665308?

This trial is currently completed. The enrollment target is 97 participants. The study started on 2025-01-13. Estimated completion is 2025-11-26.

What interventions are being tested in trial NCT06665308?

The interventions under investigation include: No intervention (OTHER).

Who is sponsoring clinical trial NCT06665308?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT06665308, the US trial registry maintained by the National Library of Medicine. NCT06665308 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.