Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 264
- 试验地点
- 30
- 主要终点
- Incidence of all SAEs
研究概览
简要总结
The purpose of the proposed study is to acquire additional data (including the assessment of anti-rHuPH20 antibodies) on the long-term safety of HYQVIA and to assess the prescribed treatment regimens and treatment administration in routine clinical practice.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant requires immunoglobulin treatment for primary immunodeficiency disease (PIDD)
- •Participant age is compatible with local package insert requirements
- •Participant has been prescribed or has started treatment with HYQVIA (Immune Globulin (Human) 10% with rHuPH20)
- •Participant is willing and able to comply with the requirements of the protocol.
- •Female participant of child-bearing potential agrees to inform the investigator if she becomes pregnant, or plans to become pregnant during the course of the study
排除标准
- •Participant has known hypersensitivity to any of the components of the medicinal product
- •Participant has participated in an interventional clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in an interventional clinical study involving a medical product or device during the course of this study
- •Participant is a family member or employee of the investigator
- •Participant is planning to become pregnant, pregnant or breastfeeding at the time of enrollment
结局指标
主要结局
Incidence of all SAEs
时间窗: Throughout the study period of approximately 5 1/2 years
Health resource use: length of hospital stay
时间窗: Throughout the study period of approximately 5 1/2 years
Incidence of Infections
时间窗: Throughout the study period of approximately 5 1/2 years
Treatment Administration: Mean rate of infusion
时间窗: Throughout the study period of approximately 5 1/2 years
Health resource use: hospitalizations
时间窗: Throughout the study period of approximately 5 1/2 years
Incidence and titer of binding and neutralizing antibodies to rHuPH20
时间窗: Throughout the study period of approximately 5 1/2 years
Treatment Administration: Maximum infusion rate
时间窗: Throughout the study period of approximately 5 1/2 years
Health Related Quality of Life: EuroQol 5-Dimension (EQ-5D) Questionnaire
时间窗: Every 3 months in first year of study, annually for remainder of study
Health Related Quality of Life: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9)
时间窗: Every 3 months in first year of study, annually for remainder of study
Health Related Quality of Life: Treatment Preference Questionnaire
时间窗: Annually throughout the study
Health resource use: acute care visits
时间窗: Throughout the study period of approximately 5 1/2 years
Days missed from work/school
时间窗: Throughout the study period of approximately 5 1/2 years
Incidence of all related serious adverse events (SAEs)
时间窗: Throughout the study period of approximately 5 1/2 years
Treatment Regimen: Infusion interval
时间窗: Throughout the study period of approximately 5 1/2 years
Treatment Administration: Number of infusion sites per infusion
时间窗: Throughout the study period of approximately 5 1/2 years
Health Related Quality of Life: Short Form-36 (SF-36)
时间窗: Every 3 months in first year of study, annually for remainder of study
Health resource use: Emergency Room visits
时间窗: Throughout the study period of approximately 5 1/2 years
Incidence of non-serious adverse events (AEs), related and not related, local and systemic.
时间窗: Throughout the study period of approximately 5 1/2 years
Treatment Regimen: Total dose administered
时间窗: Throughout the study period of approximately 5 1/2 years
Treatment Administration: Actual volume per infusion
时间窗: Throughout the study period of approximately 5 1/2 years
Treatment Administration: Duration of infusion
时间窗: Throughout the study period of approximately 5 1/2 years
次要结局
未报告次要终点