Efficacy of Mini-pool Intravenous Immunoglobulin (MP-IVIG) Prepared by Assiut University Hospital Blood Bank in Guillain-Barré Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Safety of MP-IVIG assessed by percentage of adverse Events: Overall percentage of adverse events
研究概览
简要总结
- study the pharmacokinetics of mini-pooled intravenous immunoglobulin( MP-IVIG)
- to determine the efficacy of intravenous immunoglobulin (IVIg) in hastening recovery and reducing the complications of Guillain-Barré syndrome (GBS).
- The MP-IVIG was tolerated and presented no safety issues in a previous study and we will be confirmed by monitoring any adverse events (anaphylaxis and haemolysis) ( no or mild or moderate) and reporting them to ethical committee safety monitoring group.
- Efficacy will be confirmed by:
- Patient able to walk
- Improvement of general health.
- Integration in to social live
- to compare the efficacy of IVIg to plasma exchange (PE) in hastening recovery and improving the condition of GBS
详细描述
Guillain-Barré syndrome (GBS) is a frequent cause of neuromuscular paralysis occurring at all ages. The incidence of GBS is reported to be 1.2-2.3 per 100,000 per year .
GBS is a post infectious disorder. The most frequently identified preceding infection is Campylobacter jejuni. Others are cytomegalovirus, Epstein-Barr virus, Mycoplasma pneumoniae, and Haemophilus influenzae . Many reports have documented the occurrence of GBS shortly after vaccinations, operations, or stressful events, but the causality and pathophysiology are still debated .
Rapidly progressive weakness is the core clinical feature of GBS. By definition, maximal weakness is reached within 4 weeks, but most patients reach it within 2 to 3 weeks. Thereafter, patients enter a plateau phase that ranges from days to several weeks or months . This phase is followed by a usually much slower and variable recovery phase. In Europe, about one-third of GBS patients remain able to walk ("mild patients") .about 25% of the GBS patients who are unable to walk ("severe patients") need artificial ventilation. This is predominantly due to weakness of the respiratory muscles. GBS has a great impact on social life and the ability to perform activities of daily life. therefore, GBS remains a severe disease for which better treatments are required .
. Magdy EL-Ekiaby, et al 2010 introduce the concept of small-scale ("minipool") plasma processing methods. The preparation of the Immunoglobulin G (IgG) plasma fractionation from 20 blood donations which are tested for anti-A and anti-B titre < 32. Implementable with minimum infrastructural requirements. They developed viral inactivation and protein purification technologies in single-use equipment to prepare virally safe solvent/detergent-filtered (S/D-F) plasma Producing a 90%pure immunoglobulin fraction in disposable single-use devices for transfusion .
IVIG adverse events (AEs) are not frequent; hemolysis after IVIG is a known, rare complication. Higher doses and non-O blood group are key risk factors. The incidence of post-IVIG hemolysis is estimated at 1 per 1000 IVIG treatment episodes, most of which occur within 2 days of exposure. Although the preparation of blood group specific IVIGs in industry is a complex issue because of the pooling of thousands of plasma donations per batch, the preparation of blood group-specific mini-pool IVIG (MP-IVIG) is possible because each pool consists of only 20 plasma donations. Blood group-matched MP-IVIG is assumed to reduce the incidence of IVIG-associated hemolysis, which is largely caused by the presence of anti-A and anti-B agglutinins reacting with non-O blood group recipients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age group: 18-40 years.
- •Both sex are include
- •The study will include patient diagnosed as Guillain-Barré syndrome (mild) cases in neuropsychiatric hospital at Assiut university hospitals.
排除标准
- •• Patient has severe form of Guillain-Barré syndrome (GBS) according to GBS disability score
- •Patient with renal impairment
- •Patient with hepatic cell failure
结局指标
主要结局
Safety of MP-IVIG assessed by percentage of adverse Events: Overall percentage of adverse events
时间窗: 72 hour after adminstration of MP-IVIG and between 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 temperature 2)Hemolysis by hemoglobin level, Lactate dehydrogenase( LDH),bilirubin level.2)between infusions by home diaries.
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 Blood samples for analysis of pharmacokinetics MP-IVIG plasma concentration -time curve were obtained and analysed
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 trough levels
时间窗: predose sample
MP-IVIG trough level concentration values of serum total IgG pre the MP-IVIG infusion (if applicable).
Efficacy ofMini-pool Intravenous Immunoglobulin (MP-IVIG) assessed by patients achieve score more than or equal 2 according to GBS disability score
时间窗: 6 MONTHS
Guillain-Barré syndrome disability scale Score Description 0 A healthy state 1. Minor symptoms and capable of running 2. Able to walk 10m or more without assistance but unable to run 3. Able to walk 10m across an open space with help 4. Bedridden or chairbound 5. Requiring assisted ventilation for at least part of the day 6. Dead
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
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 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
次要结局
- • compare the efficacy of IVIg to plasma exchange (PE) according to GBS disability score(6 MONTHS)
研究者
Hend Ahmed Hassan Moubark
clinical pathology specialist at assiut university hospitals blood banks
Assiut University
