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

NCT04550611 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-01-14

No results posted yet for this study

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

Conditions

  • Guillain-Barre Syndrome

Interventions

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.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Maha A Mohamed, Prof · Assiut University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2022-11-30
Completion
2022-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04550611 on ClinicalTrials.gov