NCT00391131已完成3 期
A Multi-centre, Open-label Study to Assess the Efficacy, Tolerability, Safety and Pharmacokinetics of Subcutaneous Infusions of Ig NextGen 16% in Patients With Primary Immunodeficiency (PID).
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- CSL Limited
- 入组人数
- 35
- 试验地点
- 12
- 主要终点
- Efficacy
研究概览
简要总结
This study aims to assess the safety, tolerability, efficacy and pharmacokinetics of Ig NextGen 16% in people with antibody deficiency currently being treated with IntragamP. Ig NextGen 16% is a liquid immunoglobulin (antibody) preparation manufactured using predominately chromatographic techniques. Eligible patients will switch from monthly intravenous IntragamP therapy to weekly subcutaneous Ig NextGen 16% treatment. Initial hospital training will be required for subcutaneous administration and then the patient will perform the infusion in their own home, returning once a month for a supervised infusion. Patients will be monitored on the study for up to 10 months to assess blood IgG levels and rate of serious bacterial infections.
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
- •Inclusion Criteria:
- •Males or females 3 years of age or greater and at least 13 kg at enrolment.
- •PID patients receiving Ig replacement therapy, with a diagnosis of X-linked agammaglobulinemia (XLA) or Common Variable immunodeficiency (CVID) with severe hypogammaglobulinemia.
- •Patients who have received a consistent dose of Intragam®P at 3-, 4-, 5- or 6-weekly intervals, within the range of 0.2 - 0.6 g/kg body weight, for at least six months prior to the Screening visit.
- •Patients must have maintained IgG trough serum level of ≥ 5 g/L during the six months prior to Visit 0, with at least two trough levels to have been documented during this period.
- •Patients and/or their legally acceptable representative/guardian must give written informed consent to participate in the study and must understand the nature of the study and must be willing to comply with all protocol requirements
排除标准
- •• Patients newly diagnosed with PID within six months of the Screening visit.
- •Patients with known or suspected severe hypersensitivity or previous evidence of severe side effects to immunoglobulin therapy or other blood products
- •Patients with known selective IgA deficiency or antibodies to IgA
- •Patients receiving immunosuppressive treatment other than topical and/or inhaled steroids and low dose oral steroids.
- •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 with protein-losing enteropathies, and kidney diseases with substantial proteinuria
- •Patients with malignancies of lymphoid cells such as chronic lymphocytic leukaemia, Non-Hodgkin's lymphoma and immunodeficiency with thymoma.
- •Patients who have within 30 days priors to the study screening visit, participated in a clinical study or used an investigational compound (eg: a new chemical entity not registered for clinical use).
- •Patients with any of the following abnormal lab results:
- •Serum creatinine >1.5 x Upper limit of Normal (ULN).
- •Serum ALT & AST > 2.5 x ULN.
- •Albumin < 25 g/L
- •Patients who are suffering from an acute or chronic medical condition, other than PID, which may, in the opinion of the Investigator, affect the conduct of the trial.
- •Patients who are not willing or are unable to comply with protocol.
研究组 & 干预措施
Ig NextGen 16%
Experimental
干预措施: IgNextGen 16% (Drug)
结局指标
主要结局
Efficacy
时间窗: Continually from Visits 7 to 12 & monthly IgG troughs
次要结局
- Safety, Tolerability, Quality of Life, Pharmacokinetics(Visits 0, 6, 9, and12)
研究者
研究点 (12)
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