Mini-pool Intravenous Immunoglobulin (MP-IVIG) in Guillain-Barré Syndrome
- Conditions
- Guillain-Barre Syndrome
- Interventions
- Other: plasma exchangeOther: Mini-pool Intravenous Immunoglobulin (MP-IVIG)
- Registration Number
- NCT04550611
- Lead Sponsor
- Assiut University
- Brief Summary
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
3. to compare the efficacy of IVIg to plasma exchange (PE) in hastening recovery and improving the condition of GBS
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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.
-
• Patient has severe form of Guillain-Barré syndrome (GBS) according to GBS disability score
- Patient with renal impairment
- Patient with hepatic cell failure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description plasmapheresis plasma exchange plasma exchange (plasmapheresis ) in a regimen of removing of 1.3 plasma volumes in each cycle for total of five cycle for five consecutive days within four weeks of onset of symptoms. Mini-pool Intravenous Immunoglobulin (MP-IVIG) Mini-pool Intravenous Immunoglobulin (MP-IVIG) will receive blood group -specific MP-IVIG in a regimen of 2 g/kg bodyweight, usually as 0.4 g/kg bodyweight per day for five consecutive days within two weak of onset of symptoms.
- Primary Outcome Measures
Name Time Method Safety of MP-IVIG assessed by percentage of adverse Events: Overall percentage of adverse events 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 [ (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 (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 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 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. DeadStudy the pharmacokinetics MP-IVIG Cmax (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). : ( 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 (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. (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
- Secondary Outcome Measures
Name Time Method • compare the efficacy of IVIg to plasma exchange (PE) according to GBS disability score 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