An Open-Label Study of Ig NextGen 16% Administered by Subcutaneous Infusion in Patients With Primary Immunodeficiency (PID).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- CSL Limited
- 入组人数
- 41
- 试验地点
- 9
- 主要终点
- Rate, Severity and Relatedness of reported Adverse Events
研究概览
简要总结
The study aims to assess the safety and tolerability of subcutaneous Ig NextGen 16% in patients with Primary Immune Deficiency who require Immunoglobulin (Ig) G replacement therapy. Ig NextGen 16% is a liquid immunoglobulin (antibody) preparation.
详细描述
This is a Phase 3, open label, multi-centre, study for patients requiring Ig replacement therapy. This study is a follow-on study to patients who have completed the CSLCT-SCIG-05-23 clinical trial and wish to continue subcutaneous treatment with Ig NextGen 16% . Additionally, patients currently receiving IVIg with unacceptable adverse reactions or unable to tolerate IVIg as well as patients receiving alternate IG products via the SC route may be enrolled in this study. Patients must not be eligible for any of the Sponsor's ongoing PID studies that are still open to enrolment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age >3 years of age.
- •PID patients receiving Ig replacement therapy.
- •Patients must have completed or withdrawn from CSLCT-SCIG-05-23 and wish to continue SCIg therapy; or, patients ineligible for CSLCT-SCIG-05-23 but for whom the Investigator believes SCIg may be a suitable form of Ig replacement, for reasons such as: poor tolerability of IVIg, difficult venous access, or, preferred route of administration.
- •Patient is capable of self-administering Ig NextGen 16%
排除标准
- •Patients eligible for CSLCT-SCIG-05-23 if still open for recruitment.
- •Patients with known anaphylaxis reactions to immunoglobulin therapy.
- •Patients with known selective IgA deficiency or antibodies to IgA with a history of reactions to Ig therapy.
- •Patients with protein-losing enteropathies.
- •Patients who are suffering from an acute or chronic medical condition, other than PID, which may, in the opinion of the Investigator, affect their treatment or the conduct of the trial.
- •Females who are pregnant, breast feeding or planning a pregnancy during the course of the study. Females who are of child bearing potential must have a negative pregnancy test at screening.
- •Patients unwilling to comply with the protocol.
研究组 & 干预措施
1
干预措施: Immunoglobulin G (Ig NextGen 16%) (Drug)
结局指标
主要结局
Rate, Severity and Relatedness of reported Adverse Events
时间窗: Up to Four Years
次要结局
- To monitor patient IgG trough levels while receiving Ig NextGen 16%(Up to 4 years)