NCT04550611

Mini-pool Intravenous Immunoglobulin (MP-IVIG) in Guillain-Barré Syndrome

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Guillain-Barre Syndrome

Interventions

Type	Name	Description
OTHER	Mini-pool Intravenous Immunoglobulin (MP-IVIG)	The process of MP-IVIG preparation will involve the use of caprylic acid for purification and virus inactivation of Igs from mini-pools of 20 plasma donations collected in our CBTS in AUH. The equipment used for the process comprised disposable blood bags, hemodialyzers, and purification and microbial filters.
OTHER	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.

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-11-01
• Completion: 2022-12-01
• First posted: 2020-09-16
• Last updated: 2021-01-14