NCT00405184已完成3 期
A Multi-centre, Open-label, Cross-over Study to Compare the Pharmacokinetics, Safety and Tolerability of Ig NextGen 10% With Intragam P in Patients With Primary Immune Deficiency (PID)
适应症
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
- 19
- 试验地点
- 4
- 主要终点
- IgG Trough Pharmacokinetics
研究概览
简要总结
This study aims to assess the safety, tolerability and pharmacokinetics of Ig NextGen 10% in patients with primary immune deficiency currently being treated with Intragam P. Eligible patients will switch from 3 to 4 weekly intravenous Intragam P therapy to receive seven cycles of Ig NextGen 10% treatment administered intravenously at three- to four-weekly intervals. Patients will be monitored on the study for up to 36 weeks.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of PID
- •= or >6 month use of Intragam P at three- or four-weekly intervals
- •= or >6 month history of IgG trough levels of ≥ 5 g/L
排除标准
- •Newly diagnosed PID within six months prior to Screening
- •Known selective IgA deficiency or antibodies to IgA
- •Immunosuppressive treatment other than topical and/ or inhaled steroids and/ or low dose oral steroids
- •Protein-losing enteropathies, or kidney diseases
- •History of malignancies of lymphoid cells
- •Any of the following laboratory results at Screening:
- •Serum Creatinine > 1.5 times the upper normal limit (UNL)
- •AST or ALT concentration > 2.5 times the UNL
- •Albumin < 25 g/L
结局指标
主要结局
IgG Trough Pharmacokinetics
时间窗: one month
次要结局
- Safety and tolerability, Pharmacokinetics(9 months)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
3 期
Subcutaneous Ig NextGen 16% in PID PatientsPrimary Immunodeficiency (PID)NCT00391131CSL Limited35
已完成
3 期
Treatment of Chronic Immune Thrombocytopenic Purpura (ITP) With Intravenous Immunoglobulin IgPro10Immune Thrombocytopenic PurpuraNCT00168038CSL Behring58
终止
1 期
Study of VAY736 as Single Agent and in Combination With Select Antineoplastic Agents in Patients With Non-Hodgkin LymphomaNon-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone LymphomaNCT04903197Novartis Pharmaceuticals18
已完成
3 期
Safety Study of Subcutaneous Ig NextGen 16% in Patients With Primary ImmunodeficiencyPrimary Immune DeficiencyNCT00680446CSL Limited41
已完成
1 期
A Study to Compare the Blood Level of Bimekizumab Injected Subcutaneously Either by a Prefilled Syringe or by an Auto-injector in Adult Healthy Volunteer ParticipantsHealthy VolunteersNCT03707717UCB Biopharma S.P.R.L.189