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临床试验/NCT06662825
NCT06662825已完成不适用

SEG-2022-01 Patient Characteristics and Treatment Patterns From Early Crizanlizumab Use in Real-world Setting: Preliminary Analysis From Select Sickle Cell Centers

Novartis1 个研究点 分布在 1 个国家目标入组 376 人开始时间: 2022年12月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Novartis
入组人数
376
试验地点
1
主要终点
Age at Index Date

研究概览

简要总结

This was a retrospective cohort study using secondary data from member sites of the National Alliance of Sickle Cell Centers (NASCC) with patients who had initiated crizanlizumab between 2019 and 2022.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Age at Index Date

时间窗: Day 1 of Year 2

Index date was defined as the date of the first crizanlizumab infusion

Gender at Index Date

时间窗: Day 1 of Year 2

Index date was defined as the date of the first crizanlizumab infusion

Race

时间窗: Day 1 of Year 2

Ethnicity

时间窗: Day 1 of Year 2

Insurance Type at Index Date

时间窗: Day 1 of Year 2

Index date was defined as the date of the first crizanlizumab infusion

Number of Patients Categorized by Comorbidity

时间窗: Baseline

Number of Patients who Received Long-acting Opioid Medication Before Starting Crizanlizumab

时间窗: Baseline

Number of Patients who Received Chronic Red Blood Cell Transfusion Therapy Before Starting Crizanlizumab Categorized by Duration of Therapy

时间窗: Baseline

Red blood cell transfusion therapy time intervals: * 0-3 months * 3-6 months * 6-12 months * \>12 months * Unknown

Number of Patients who Received Chronic Red Blood Cell Transfusion Therapy After Starting Crizanlizumab Categorized by Duration of Therapy

时间窗: Up to 1 year

Red blood cell transfusion therapy time intervals: * 0-3 months * 3-6 months * 6-12 months * \>12 months * Unknown

Number of Patients by Type of Disease Modifying Therapy (DMT) Received Pre- and Post-index Date

时间窗: Up to 2 years

Index date was defined as the date of the first crizanlizumab infusion. DMTs included: * Any SCD specific therapy * Hydroxyurea * Voxelotor * L-Glutamine * Other

次要结局

  • Number of Doses Received by Patients Who Continued and Discontinued Crizanlizumab Treatment(1 year)
  • Number of SCD-related Hospitalizations and Emergency Department Visits Pre- and Post-index Date(Up to 2 years)
  • Length of Stay of SCD-related Hospitalization Visits Pre- and Post-index Date(Up to 2 years)

研究者

发起方
Novartis
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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