Cognitive Status, Fatigue, and Inflammation in Patients With Immune Thrombocytopenic Purpura (ITP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 97
- 试验地点
- 4
- 主要终点
- Prevalence of impaired cognitive status among adult Immune Thrombocytopenia patients
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
结局指标
主要结局
Prevalence of impaired cognitive status among adult Immune Thrombocytopenia patients
时间窗: 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.
次要结局
- Age, sex, ethnicity, educational attainment(Day 1 (Index date))
- Comorbidities at index categorical(Day 1 (Index date))
- Smoking, alcohol, marijuana, cocaine use(Day 1 (Index date))
- ITP Bleeding Scale (IBLS)(Day 1 (Index date))
- FACIT (Functional Assessment of Chronic Illness Therapy) - Fatigue score(Day 1 (Index date))
- Medical history(Day 1 (Index date))
- Current medications(Day 1 (Index date))
- Laboratory characteristics(Day 1 (Index date))
- ITP-PAQ(Day 1 (Index date))
- Assessment of key inflammatory biomarkers(Day 1 (Index date))