Study of Safety and Efficacy of Mini-pool Intravenous Immunoglobulin (MP-IVIG) Prepared by Assiut University Hospital Blood Bank in Primary Immunodeficiency Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Efficacy of MP-IVIG assessed by the incidence of acute Serious Bacterial infections(SBIs)
研究概览
简要总结
- study the pharmacokinetics of mini-pooled intravenous immunoglobulin( MP-IVIG)
- Study the safety and efficacy of a newly developed preparation of MP-IVIG in children with primary immunodeficiency (PID) :
- Adverse reaction of MP-IVIG(anaphylaxis and haemolysis)( no or mild or moderate)
- Prevention of severe bacterial infection
- Improvement of general health(weight gain and mentality)
- Integration in to social live
- Compare the efficacy of MP-IVIG to standard IVIG in children with primary immunodeficiency (PID).
详细描述
Primary immunodeficiency diseases (PID) are a heterogeneous group of inherited disorders of the immune system, predisposing individuals to recurrent infections, allergy, autoimmunity, and malignancies. Clinical descriptions have already been made for more than 200 PIDs, for which over 150 forms of PID have been molecularly characterized .
A population prevalence of diagnosed PID in the United States at approximately 1 in 1,200 persons.
A part from local registration in some centres there is no national registry of PID in Egypt, and hence, the prevalence of these disorders in the investigator's population is still unknown .
An increasing number of PID are recognized, and effective treatments are possible. Early use of prophylactic antibiotics and replacement immunoglobulin can prevent significant end organ damage and improve long quality of life in these patients .
Immunoglobulin G (IgG) is an essential plasma derived medicine that is lacking in developing countries .IgG shortages leave immune deficient patients without treatment, exposing them to devastating recurrent infections from local pathogens. A simple and practical method for producing IgG from normal plasma collected in developing countries is needed to provide better, faster access to IgG for patients .
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age group: children patients under 18 years.
- •The study will include patient diagnosed as primary immunodeficiency disease (PID) in Assiut university hospital on standard IVIG therapy.
排除标准
- •Patient has SCID.
- •Patient with history of severe IVIG side effect.
- •Patient with severe immunodeficiency and has severe disseminated infection.
- •Patient with renal impairment
- •Patient with hepatic cell failure
- •Patient with endocrinal abnormalities
- •patient with secondary immunodeficiency diseases
结局指标
主要结局
Efficacy of MP-IVIG assessed by the incidence of acute Serious Bacterial infections(SBIs)
时间窗: 1 year
The rate of Acute SBIs for each participant per 1 year will be assessed by questionnaire (Serious Bacterial Infections) include sign and symptoms of acute serious bacterial infections, i.e. bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, osteomyelitis/ septic arthritis, visceral abscess.
Study the pharmacokinetics- MP-IVIG trough levels
时间窗: predose sample
MP-IVIG trough level concentration values of serum total IgG pre the MP-IVIG infusion (if applicable).
Study the pharmacokinetics MP-IVIG plasma concentration -time curve
时间窗: (1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose
Blood samples for analysis of pharmacokinetics MP-IVIG plasma concentration -time curve were obtained and analysed
Safty of MP-IVIG assessed by percentage of adverse Events
时间窗: 72 hour after adminstration of MP-IVIG and betwen infusions period
Overall percentage of adverse events as hemolysis and anaphylaxis headache and other complains that occur during 72 hours of following an infusion of MP-IVIG will be assessed by1) vital sign(pulse,blood pressure,Respiratory rate and temprature 2)Hemolysis by hemoglobin level,LDH,billirubin level.2)lbetwen infusions by home diaries.
Study the pharmacokinetics MP-IVIG half-life
时间窗: (1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose
Blood samples for analysis of pharmacokinetics MP-IVIG haf-life were obtained and analysed
Study the pharmacokinetics MP-IVIG area under the curve
时间窗: (1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose
Blood samples for analysis of pharmacokinetics MP-IVIG haf-life were obtained and analysed
Study the pharmacokinetics of MP-IVIG-Tmax.
时间窗: (1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose
Blood samples for analysis of pharmacokinetics MP-IVIG Tmax were obtained and analysed
Study the pharmacokinetics of MP-IVIG elimination rate constant(s).
时间窗: (1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose
Blood samples for analysis of pharmacokinetics MP-IVIG elimination rate constant(s) were obtained and analysed
Study the pharmacokinetics MP-IVIG Cmax
时间窗: (1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose
Blood samples for analysis of pharmacokinetics MP-IVIG Cmax were obtained and analysed
次要结局
- Compare efficacy of MP-IVIG vs standard IVIG by compare incidence of SBIs of both(1 year)
研究者
Alshaimaa Mokhtar Selim mohamed
Principal investigator
Assiut University