Clinical trial NCT06665308: Cognitive Status, Fatigue and Inflammation in Patients With Immune Thrombocytopenia (ITP)
Official title: Cognitive Status, Fatigue, and Inflammation in Patients With Immune Thrombocytopenic Purpura (ITP)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Immune Thrombocytopenia
Primary Immune Thrombocytopenia
Adult Immune Thrombocytopenia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-10-30
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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).

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with chronic (ITP with \> 1 year duration) primary ITP living in the USA or the UK:
* On ITP pharmacologic treatment, regardless of last platelet count (below or above 100 x 10\^9 counts/L);
* Patients in remission as per their most recent blood test (platelet count \>100 x 10\^9 counts/L) and without ITP-specific treatment for less than 1 year
* Adult patient who are 18 years or older at index date
* Patient who has received at least one initial first line therapy (corticosteroids \[CS\]/ intravenous immunoglobulin \[IVIg\]/ANTI d) with initial response (platelet count ≥ 50 x 10\^9 counts/L) as of index date

Exclusion Criteria:

* Secondary ITP
* Patients in remission as per their most recent blood test (platelet count \>100 x 10\^9 counts/L) and without ITP-specific treatment for 1 year or more
* 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

Primary outcomes:
measure: Prevalence of impaired cognitive status among adult Immune Thrombocytopenia patients
timeFrame: Day 1 (Index date)
Secondary outcomes:
measure: Age, sex, ethnicity, educational attainment
timeFrame: Day 1 (Index date)
measure: Smoking, alcohol, marijuana, cocaine use
timeFrame: Day 1 (Index date)
measure: Comorbidities at index categorical
timeFrame: Day 1 (Index date)
measure: Current medications
timeFrame: Day 1 (Index date)
measure: ITP-PAQ
timeFrame: Day 1 (Index date)
measure: ITP Bleeding Scale (IBLS)
timeFrame: Day 1 (Index date)
measure: Medical history
timeFrame: Day 1 (Index date)
measure: Laboratory characteristics
timeFrame: Day 1 (Index date)
measure: Assessment of key inflammatory biomarkers
timeFrame: Day 1 (Index date)
measure: FACIT (Functional Assessment of Chronic Illness Therapy) - Fatigue score
timeFrame: Day 1 (Index date)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center- Site Number : 8400002
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital- Site Number : 8400001
state: Massachusetts
city: Seattle
country: United States
facility: University of Washington-Fred Hutchinson Cancer Center_Site Number: 8400003
state: Washington
city: London
country: United Kingdom
facility: Investigational Site Number: 8260001
state: London, City Of
Study officials:
References: