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临床试验/NCT03716700
NCT03716700已完成不适用

Real-world CANadian CUvitru Non-Interventional Study in Subjects Transitioning From Subcutaneous Immunoglobulin (CANCUN)

Baxalta now part of Shire3 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2018年9月24日最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
126
试验地点
3
主要终点
Infusion parameter 1: Cohort 1-Start of data collection
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will provide insights on the infusion parameters, dosing, and experience of participants transitioning to CUVITRU in a real-world setting.

研究设计

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

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Infusion parameter 1: Cohort 1-Start of data collection

时间窗: Baseline

Median infusion volume per site

Infusion parameter 1: Cohort 1- Month 6

时间窗: Month 6

Median infusion volume per site

Infusion parameter 1.1: Cohort 1- Start of data collection

时间窗: Baseline

Median infusion volume per infusion

Infusion parameter 1.1: Cohort 1- Month 3

时间窗: Month 3

Median infusion volume per infusion

Infusion parameter 1.1: Cohort 1- Month 6

时间窗: Month 6

Median infusion volume per infusion

Infusion parameter 1.1: Cohort 2- Start of data collection

时间窗: Baseline

Median infusion volume per infusion

Infusion parameter 2: Cohort 1- Start of data collection

时间窗: Baseline

Median number of infusion sites

Infusion parameter 2: Cohort 1- 12 Month final follow-up

时间窗: 12 Month final follow-up

Median number of infusion sites

Infusion parameter 3: Cohort 2- Start of data collection

时间窗: Baseline

Median infusion duration

Infusion parameter 1: Cohort 1- Month 3

时间窗: Month 3

Median infusion volume per site

Infusion parameter 1: Cohort 2- 12 Month final follow-up

时间窗: 12 Month final follow-up

Median infusion volume per site

Infusion parameter 1.1: Cohort 2- 12 Month final follow-up

时间窗: 12 Month final follow-up

Median infusion volume per infusion

Infusion parameter 3.1: Cohort 1- Month 6 Follow-up

时间窗: Month 6

Median number of infusions to reach participant's maximum infusion volume

Infusion parameter 3.1: Cohort 1- 12 Month final follow-up

时间窗: 12 Month final follow-up

Median number of infusions to reach participant's maximum infusion volume

Infusion parameter 3.1: Cohort 2- 12 Month final follow-up

时间窗: 12 Month final follow-up

Median number of infusions to reach participant's maximum infusion volume

Infusion parameter 3.2: Cohort 1- Month 3

时间窗: Month 3

Median number of infusions per month per participant

Infusion parameter 3.3: Cohort 1- 12 Month final follow-up

时间窗: 12 Month final follow-up

Median number of infusions to reach final dose interval per participant

Infusion parameter 1: Cohort 3- 12 Month Final Follow-up

时间窗: 12 Month final follow-up

Median infusion volume per site.

Infusion parameter 1.1: Cohort 3- 12 Month Final Follow-up

时间窗: 12 Month final follow-up

Median infusion volume per infusion.

Infusion parameter 3.1: Cohort 3- 12 Month final follow-up

时间窗: 12 Month final follow-up

Median number of infusions to reach participant's maximum infusion volume (infusion rate)

Infusion parameter 1: Cohort 1- 12 Month final follow-up

时间窗: 12 Month final follow-up

Median infusion volume per site

Infusion parameter 1.1: Cohort 1- 12 Month final follow-up

时间窗: 12 Month final follow-up

Median infusion volume per infusion

Infusion parameter 2: Cohort 1- Month 3

时间窗: Month 3

Median number of infusion sites

Infusion parameter 2: Cohort 1- Month 6

时间窗: Month 6

Median number of infusion sites

Infusion parameter 2: Cohort 2- Start of data collection

时间窗: Baseline

Median number of infusion sites

Infusion parameter 3: Cohort 1- Start of data collection

时间窗: Baseline

Median infusion duration

Infusion parameter 3: Cohort 1- Month 3

时间窗: Month 3

Median infusion duration

Infusion parameter 3: Cohort 1- 12 Month final follow-up

时间窗: 12 Month final follow-up

Median infusion duration

Infusion parameter 3: Cohort 2- 12 Month final follow-up

时间窗: 12 Month final follow-up

Median infusion duration

Infusion parameter 1: Cohort 2- Start of data collection

时间窗: Baseline

Median infusion volume per site

Infusion parameter 3.1: Cohort 1- Month 3 Follow-up

时间窗: Month 3

Median number of infusions to reach participant's maximum infusion volume

Infusion parameter 3.3: Cohort 1- Start of data collection

时间窗: Baseline

Median number of infusions to reach final dose interval per participant

Infusion parameter 3.3: Cohort 1- Month 6

时间窗: Month 6

Median number of infusions to reach final dose interval per participant

Infusion parameter 2: Cohort 3- 12 Month final follow-up

时间窗: 12 Month final follow-up

Median number of infusion sites.

Infusion parameter 3: Cohort 3- 12 Month final follow-up

时间窗: 12 Month final follow-up

Median infusion duration.

Infusion parameter 2: Cohort 2- 12 Month final follow-up

时间窗: 12 Month final follow-up

Median number of infusion sites

Infusion parameter 3: Cohort 1- Month 6

时间窗: Month 6

Median infusion duration

Infusion parameter 3.2: Cohort 1- Start of data collection

时间窗: Baseline

Median number of infusions per month per participant

Infusion parameter 3.2: Cohort 2- 12 Month final follow-up

时间窗: 12 Month final follow-up

Median number of infusions per month per participant

Infusion parameter 3.2: Cohort 3- 12 Month final follow-up

时间窗: 12 Month final follow-up

Median number of infusions per month per participant

Infusion parameter 3.2: Cohort 1- Month 6

时间窗: Month 6

Median number of infusions per month per participant

Infusion parameter 3.2: Cohort 1- 12 Month final follow-up

时间窗: 12 Month final follow-up

Median number of infusions per month per participant

Infusion parameter 3.2: Cohort 2- Start of data collection

时间窗: Baseline

Median number of infusions per month per participant

Infusion parameter 3.3: Cohort 2- Start of data collection

时间窗: Baseline

Median number of infusions to reach final dose interval per participant

Infusion parameter 3.3: Cohort 2- 12 Month final follow-up

时间窗: 12 Month final follow-up

Median number of infusions to reach final dose interval per participant

Infusion parameter 3.3: Cohort 1- Month 3

时间窗: Month 3

Median number of infusions to reach final dose interval per participant

Infusion parameter 3.3: Cohort 3- 12 Month final follow-up

时间窗: 12 Month final follow-up

Median number of infusions to reach final dose interval per participant

次要结局

  • Infusion parameter 4.1: Cohort 1- Month 6(Month 6)
  • Infusion parameter 4.1: Cohort 2- Start of data collection(Baseline)
  • Infusion parameter 5.1: Cohort 1- 12 Month final follow-up(12 Month final follow-up)
  • Infusion parameter 4.1: Cohort 1- Month 3(Month 3)
  • Infusion parameter 4.1: Cohort 2- 12 Month final follow-up(12 Month final follow-up)
  • Infusion parameter 4.2: Cohort 1- Month 3(Month 3)
  • Infusion parameter 4.2: Cohort 1- Month 6(Month 6)
  • Infusion parameter 5.1: Cohort 1- Start of data collection(Baseline)
  • Infusion parameter 4.1: Cohort 3- 12 Month final follow-up(12 Month final follow-up)
  • Infusion parameter 5.1: Cohort 3- 12 Month final follow-up(12 Month final follow-up)
  • Infusion parameter 4.2: Cohort 1- Start of data collection(Baseline)
  • Infusion parameter 4.2: Cohort 2- 12 Month final follow-up(12 Month final follow-up)
  • Infusion parameter 4.3: Cohort 1- Month 6(Month 6)
  • Infusion parameter 5.1: Cohort 1- Month 6(Month 6)
  • Infusion parameter 5.1: Cohort 2- Start of data collection(Baseline)
  • Infusion parameter 5.2: Cohort 1- Start of data collection(Baseline)
  • Infusion parameter 5.2: Cohort 1- Month 3(Month 3)
  • Infusion parameter 5.2: Cohort 1- 12 Month final follow-up(12 Month final follow-up)
  • Infusion parameter 4.1: Cohort 1- Start of data collection(Baseline)
  • Infusion parameter 4.3: Cohort 1- Month 3(Month 3)
  • Infusion parameter 4.3: Cohort 1- 12 Month final follow-up(12 Month final follow-up)
  • Infusion parameter 4.3: Cohort 2- 12 Month final follow-up(12 Month final follow-up)
  • Infusion parameter 5.2: Cohort 1- Month 6(Month 6)
  • Infusion parameter 5.3: Cohort 1- Month 3(Month 3)
  • Infusion parameter 5.3: Cohort 1- Month 6(Month 6)
  • Infusion parameter 4.3: Cohort 3- 12 Month final follow-up(12 Month final follow-up)
  • Infusion parameter 5.3: Cohort 3- 12 Month final follow-up(12 Month final follow-up)
  • Life Quality Index (LQI): Cohort 3(12 Month final follow-up)
  • Infusion parameter 4.1: Cohort 1- 12 Month final follow-up(12 Month final follow-up)
  • Infusion parameter 4.2: Cohort 1- 12 Month final follow-up(12 Month final follow-up)
  • Infusion parameter 4.2: Cohort 2- Start of data collection(Baseline)
  • Infusion parameter 5.1: Cohort 1- Month 3(Month 3)
  • Infusion parameter 5.3: Cohort 2- 12 Month final follow-up(12 Month final follow-up)
  • Infusion parameter 4.2: Cohort 3- 12 Month final follow-up(12 Month final follow-up)
  • Treatment Preference Questionnaire (TPQ): Cohort 2(12 Month final follow-up)
  • Infusion parameter 5.1: Cohort 2- 12 Month final follow-up(12 Month final follow-up)
  • Infusion parameter 5.3: Cohort 1- Start of data collection(Baseline)
  • Infusion parameter 5.3: Cohort 1- 12 Month final follow-up(12 Month final follow-up)
  • Infusion parameter 5.3: Cohort 2- Start of data collection(Baseline)
  • Infusion parameter 5.2: Cohort 2- Start of data collection(Baseline)
  • Infusion parameter 5.2: Cohort 2- 12 Month final follow-up(12 Month final follow-up)
  • Infusion parameter 5.2: Cohort 3- 12 Month final follow-up(12 Month final follow-up)
  • Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9): Cohort 1(12 Month final follow-up)
  • Life Quality Index (LQI): Cohort 2(12 Month final follow-up)
  • Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9): Cohort 2(12 Month final follow-up)
  • Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9): Cohort 3(12 Month final follow-up)
  • Life Quality Index (LQI): Cohort 1(12 Month final follow-up)
  • Treatment Preference Questionnaire (TPQ): Cohort 1(12 Month final follow-up)
  • Treatment Preference Questionnaire (TPQ): Cohort 3(12 Month final follow-up)

研究者

发起方
Baxalta now part of Shire
申办方类型
Industry
责任方
Sponsor

研究点 (3)

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