NCT02176239已完成不适用
Monitoring of 5% Treatment Naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) Patients Using the CareExchange® System: A Pilot Study Using 5% Gammaplex® IVIg in the Home Setting
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Analysis of collected data captured in CareExchange will demonstrate the ability to show and track changes in outcome data in 5% treatment naïve IVIg PIDD patients in the home setting.
研究概览
简要总结
The purpose of this study is to demonstrate the utility of measuring outcomes in 5% treatment naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) patients using infusion nurse and patient measured physical, quality of life (QOL), respiratory, and disability assessments using CareExchange in the home 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
- 15 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of any form of Primary Immunodeficiency Disease
- •Males and Females
- •≥ 15 and ≤ 85 years of age
- •5% treatment Naïve IVIg for the treatment of PIDD
- •Ability to have Gammaplex® IVIg prescribed under the discretion of the patient's treating physician in accordance with standard treatment practices for the entire duration of the study
- •Ability and willingness to provide informed consent and comply with study requirements and procedures
- •Ability to read and write English
- •Understanding of study procedures and ability to comply with study procedures for the entire length of the study
- •Eligible for infusion services by AxelaCare Health Solutions, LLC, in collaboration with the subject's prescribing physician and insurance provider
排除标准
- •The presence of any medical condition that the investigator and/or prescribing physician deems incompatible with participation in this trial.
- •Prisoners, and other wards of the state
- •Determined to have non-competency of data collection requirements (physical assessments and use of an iPAD™) by either the home infusion nurse and/or Caregiver.
- •Receiving Subcutaneous Immunoglobulin (SCIg) Therapy during study participation.
结局指标
主要结局
Analysis of collected data captured in CareExchange will demonstrate the ability to show and track changes in outcome data in 5% treatment naïve IVIg PIDD patients in the home setting.
时间窗: 1 year
次要结局
- Evaluate the profile physician usage (dose and timing) with Gammaplex®.(1 year)
- Evaluate physician feedback to having real-time access to 5% treatment naïve IVIg PIDD data captured during home infusions.(1 year)
- Evaluate the safety profile of using a 5% treatment naïve IVIg in PIDD patients in the home setting.(1 year)
- Demonstration of response rate for those receiving IVIg therapies.(1 year)
- Evaluate the effectiveness of whether CareExchange leads to better QOLs and overall patient reported outcomes.(1 year)
- Demonstration of changes in outcomes as a result of changes made in IVIg dose and frequency during study participation.(1 year)
- Demonstration of measured variables within patients who receive IVIg therapies.(1 year)
- Other potential impacts on change in outcomes across patient demographics (age, sex, race, ethnicity, etc.).(1 year)
研究者
研究点 (4)
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