EUCTR2006-006745-13-FR进行中（未招募）1 期
A Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects with Primary Immunodeficiency
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 51
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •· Male or female aged > 24 months and < 65 years
- •· Subjects with primary humoral immunodeficiency, namely with a diagnosis of
- •- CVID as defined by PAGID (Pan-American Group for Immunodeficiency) and ESID (European Society for Immunodeficiencies (16))
- •- or XLA as defined by PAGID and ESID (16)
- •- or Autosomal Recessive Agammaglobulinemia
- •· Subjects who have received
- •- IVIG therapy at regular 3- or 4-week intervals
- •- or SCIG therapy at regular weekly intervals
- •at a stable dose (variations of ± 10% are allowed) for at least 6 months prior to receiving IgPro20 (maintenance dose to reach a cumulative monthly dose of the order of 0.2 – 0.8 g/kg)
- •· At least 3 documented IgG trough levels of = 5 g/L during 3 months on IVIG or SCIG replacement therapy immediately prior to receiving IgPro20; 2 of the 3 IgG trough levels may go back up to 6 months prior to receiving IgPro20, in case of stable dosing for at least 3 months prior to this assessment
- •· Chest X-ray or CT Scan obtained within 1 year prior to enrollment
- •· Women of childbearing potential using medically approved contraception and having a negative pregnancy test at screening
- •· Written informed consent
- •INCLUSION CRITERIA FOR PK SUBSTUDY
- •· Male or female aged = 6 years
- •· Written informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •· Newly diagnosed PID, i.e. subjects who have not previously received immunoglobulin replacement therapy
- •· Ongoing serious bacterial infection at the time of screening
- •· Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin’s lymphoma and immunodeficiency with thymoma
- •· Known hyperprolinemia
- •· Hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total urine protein concentration > 0.2 g/L)
- •· Allergic or other severe reactions to immunoglobulins or other blood products associated with high anti-IgA
- •· The subject is receiving steroids (oral and parenteral, daily = 0.15 mg of prednisone equivalent/kg/day) or other systemic immunosuppressants
- •· Females who are pregnant, breast feeding or planning a pregnancy during the course of the study
- •· A positive result at screening on any of the following viral markers: HIV, HCV or HBV
- •· ASAT or ALAT concentration > 2.5 times ULNR
- •· Creatinine concentration > 1.5 times ULNR
- •· Participation in a study with an investigational product other than immunoglobulin within 3 months prior to enrollment
- •· Evidence of uncooperative attitude
- •· Any condition that is likely to interfere with evaluation of the study drug or satisfactory conduct of the trial
- •· Patients who are employees at the investigational site, relatives or spouse of the investigator
研究者
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