Evaluation of Efficacy and Tolerability of Hizentra® in Subjects Transitioning From Vivaglobin® (16% SCIG Product) to Hizentra® (20% SCIG Product)
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To measure the changes in the Treatment Satisfaction Questionnaire for Medication in PIDD subjects transitioning from subcutaneous Vivaglobin® to Hizentra®.
研究概览
简要总结
The purpose of this study is to measure the changes in the Treatment Satisfaction Questionnaire for Medication in the areas of effectiveness, side effects, and convenience of administration of each medication in Primary Immunodeficiency Disorder (PIDD) subjects transitioning from subcutaneous Vivaglobin® to Hizentra®.
详细描述
This trial will evaluate subjects with Primary Immunodeficiency Disorder (PIDD) who are currently self-infusing Vivaglobin therapy for at least six months prior to changing to Hizentra® therapy. Following screening and enrollment, subjects will continue to self-infuse Vivaglobin® for seven infusions and then be converted to subcutaneous Hizentra® treatment which they will continue for the next 6 months. The study will determine if Hizentra® provides improved subject satisfaction by Treatment Satisfaction Questionnaire for Medication. Diaries related to the local site reactions, the number of infusion sites per subject/per dose, volume of Hizentra® per site, duration of infusions, systemic side effects of the new medication and dose on IgG levels and antibody titers, and local site reactions with Hizentra®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects currently self-infusing with Vivaglobin® for at least six months prior to enrollment.
- •Diagnosis of antibody deficiency due to primary immune deficiency disease.
- •Stable serum IgG levels of > 550 mg/dl while on Vivaglobin® based on two determinations at least 8 weeks apart and obtained within 6 months of entry.
- •Willing to sign consent and follow study schedule.
- •1 year to 75 years of age.
排除标准
- •Evidence of acute systemic illness or infection at within four weeks of screening or enrollment.
- •Any serious grade 3 or greater toxicity at screening.
- •History of bleeding or chronic skin disorders.
- •Selective IgA deficiency in absence of other antibody deficiencies
- •History of anaphylactic or severe systemic reaction to Vivaglobin.
- •Pregnant or breastfeeding females.
- •Use of systemic pre-medication prior to SCIG.
- •Protein losing enteropathy or nephritic syndrome.
- •Any condition that in the opinion of the investigator would interfere with the conduct of the study.
- •Subject or guardian unwilling to sign consent or adhere to study schedule.
研究组 & 干预措施
Hizentra
Compare IgG levels and site reaction in subjects transitioning from Vivaglobin to Hizentra
干预措施: Hizentra (Drug)
结局指标
主要结局
To measure the changes in the Treatment Satisfaction Questionnaire for Medication in PIDD subjects transitioning from subcutaneous Vivaglobin® to Hizentra®.
时间窗: 32 weeks
Subjects complete the TSQM at each study visit
次要结局
- To compare the incidence of local site reactions in subjects self-infusing with Vivaglobin® transitioning to Hizentra®.(32 weeks)
- To compare the steady state IgG levels in subjects self-infusing with Vivaglobin® transitioning to Hizentra®.(32 weeks)