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临床试验/NCT04550611
NCT04550611Unknown不适用

Efficacy of Mini-pool Intravenous Immunoglobulin (MP-IVIG) Prepared by Assiut University Hospital Blood Bank in Guillain-Barré Syndrome

Assiut University0 个研究点目标入组 50 人开始时间: 2021年11月最近更新:
适应症

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

  1. study the pharmacokinetics of mini-pooled intravenous immunoglobulin( MP-IVIG)
  2. 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:
  1. Patient able to walk
  2. Improvement of general health.
  3. Integration in to social live
  4. 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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hend Ahmed Hassan Moubark

clinical pathology specialist at assiut university hospitals blood banks

Assiut University

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