The Benefit of 5% IVIG for Patients With Primary Immunodeficiency Disorders Who Experience Adverse Events on 10% IVIG Preparations
2017年11月7日 更新者：IMMUNOe Research Centers
An Investigator Driven Observational Study to Determine the Benefit of Octagam 5% for Treatment of Patients Diagnosed With Primary Immunodeficiency Disorders (PID) on Intravenous Immunoglobulin (IVIG) Therapy That Experience Adverse Events (AEs) on Any 10% IVIG Preparation
Patients with primary immunodeficiency disorders (PID) on intravenous immunoglobulin (IVIG) treatment may experience adverse events (AEs).
Patients who experience AEs on any 10% IVIG solution will be changed to octagam 5% for six infusions to evaluate the potential benefit for reduction of AEs on a lower concentration IVIG product.
研究概览
地位
完全的
条件
详细说明
Patients with PID require life long immunoglobulin (Ig) replacement therapy with IVIG being the most common form.
As more 10% IVIG products are FDA approved, the older and well characterized 5% IVIG products are becoming less used.
Currently, the standard of care for patients who experience AEs on IVIG is to move to a subcutaneous (SCIG) delivery and product.
This study will evaluate the AEs on a 10% product and octagam 5%.
The study will enroll 15 patients after an AE on any 10% product who will then be infused with octagam 5% for six infusions.
AEs will be documented and compared to the 10% product along with changes in biomarkers.
The study data may document another therapeutic option for patients who experience AEs - SCIG and octagam 5%.
研究类型
观察性的
注册 (实际的)
15
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
10年 至 75年 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Diagnosis of PID - specifically common variable immunodeficiency (CVID)
描述
Inclusion Criteria:
- Participants, or legal guardians with assent by underage children, will sign informed consent/assent and are willing to comply with all aspects of the study
- Diagnosis of CVID according IUIS Expert Committee
- Participants on a 10% product who experience AEs
- Ages between 10 and 75 years of age
- Participants on 10% IVIG therapy every 21±3 days or 28±3 days between 300 - 800 mg/Kg body weight
Exclusion Criteria:
- Acute infection requiring antibiotic therapy within 7 days prior to visit 1
- Presence of any condition that is likely to interfere with the evaluation of the study medication or satisfactory conduct of the trial
- History of anaphylactic or severe systemic reactions to human immunoglobulin
- IgA deficient patients with antibodies against IgA and a history of hypersensitivity
- Females who are pregnant or lactating
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
The change in the number of AEs post-infusion between any 10% IVIG product and octagam 5%
大体时间：AEs will be documented at screening and up to 72 hours post-infusion for six infusions up to 24 weeks
|
AEs will be documented at screening and up to 72 hours post-infusion for six infusions up to 24 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The change in levels of inflammatory biomarkers associated with AEs between any 10% IVIG and octagam 5%
大体时间：Levels will be documented at screening and up to 72 hours post-infusion for six infusions up to 24 weeks
|
Levels will be documented at screening and up to 72 hours post-infusion for six infusions up to 24 weeks
|
|
|
Safety Evaluations (complete blood count [CBC])
大体时间：Screening and prior to each infusion (six infusions total) up to 24 weeks
|
CBC
|
Screening and prior to each infusion (six infusions total) up to 24 weeks
|
|
Safety evaluations (Complete Metabolic profile[CMP])
大体时间：Screening and prior to each infusion (six infusions total) up to 24 weeks
|
CMP
|
Screening and prior to each infusion (six infusions total) up to 24 weeks
|
|
Safety evaluations (IgG trough level)
大体时间：Screening and prior to last infusion up to 24 weeks
|
IgG trough level
|
Screening and prior to last infusion up to 24 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Kaveri SV, Maddur MS, Hegde P, Lacroix-Desmazes S, Bayry J. Intravenous immunoglobulins in immunodeficiencies: more than mere replacement therapy. Clin Exp Immunol. 2011 Jun;164 Suppl 2(Suppl 2):2-5. doi: 10.1111/j.1365-2249.2011.04387.x.
- Geha RS, Notarangelo LD, Casanova JL, Chapel H, Conley ME, Fischer A, Hammarstrom L, Nonoyama S, Ochs HD, Puck JM, Roifman C, Seger R, Wedgwood J; International Union of Immunological Societies Primary Immunodeficiency Diseases Classification Committee. Primary immunodeficiency diseases: an update from the International Union of Immunological Societies Primary Immunodeficiency Diseases Classification Committee. J Allergy Clin Immunol. 2007 Oct;120(4):776-94. doi: 10.1016/j.jaci.2007.08.053.
- Deane S, Selmi C, Naguwa SM, Teuber SS, Gershwin ME. Common variable immunodeficiency: etiological and treatment issues. Int Arch Allergy Immunol. 2009;150(4):311-24. doi: 10.1159/000226232. Epub 2009 Jul 1. Erratum In: Int Arch Allergy Immunol. 2010;151(4):284. Dosage error in article text.
- Maarschalk-Ellerbroek LJ, Hoepelman IM, Ellerbroek PM. Immunoglobulin treatment in primary antibody deficiency. Int J Antimicrob Agents. 2011 May;37(5):396-404. doi: 10.1016/j.ijantimicag.2010.11.027. Epub 2011 Jan 26.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年6月1日
初级完成 (实际的)
2016年11月1日
研究完成 (实际的)
2017年9月1日
研究注册日期
首次提交
2015年3月31日
首先提交符合 QC 标准的
2017年11月7日
首次发布 (实际的)
2017年11月13日
研究记录更新
最后更新发布 (实际的)
2017年11月13日
上次提交的符合 QC 标准的更新
2017年11月7日
最后验证
2017年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.