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

NCT04550611 | Unknown

• 1 other identifier: Guillain-Barré syndrome
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

• 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

Conditions

Guillain-Barre Syndrome

Outcome Measures

Primary Outcomes (9)

• Efficacy ofMini-pool Intravenous Immunoglobulin (MP-IVIG) assessed by patients achieve score more than or equal 2 according to GBS disability score

  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

  6 MONTHS

• Safety of MP-IVIG assessed by percentage of adverse Events: Overall percentage of adverse events

  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.

  72 hour after adminstration of MP-IVIG and between infusions period

• Study the pharmacokinetics- MP-IVIG trough levels

  MP-IVIG trough level concentration values of serum total IgG pre the MP-IVIG infusion (if applicable).

  predose sample

• Study the pharmacokinetics MP-IVIG plasma concentration -time curve [

  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

  (1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose ]

• Study the pharmacokinetics MP-IVIG half-life

  Blood samples for analysis of pharmacokinetics MP-IVIG haf-life were obtained and analysed

  (1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose ]

• Study the pharmacokinetics MP-IVIG area under the curve

  Blood samples for analysis of pharmacokinetics MP-IVIG haf-life were obtained and analysed

  (1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose ]

• Study the pharmacokinetics MP-IVIG Cmax

  Blood samples for analysis of pharmacokinetics MP-IVIG Cmax were obtained and analysed

  (1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose ]

• Study the pharmacokinetics of MP-IVIG-Tmax.

  Blood samples for analysis of pharmacokinetics MP-IVIG Tmax were obtained and analysed

  (1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose ]

• Study the pharmacokinetics of MP-IVIG elimination rate constant(s). : (

  Blood samples for analysis of pharmacokinetics MP-IVIG elimination rate constant(s) were obtained and analysed

  1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose ]

Secondary Outcomes (1)

• • compare the efficacy of IVIg to plasma exchange (PE) according to GBS disability score

  6 MONTHS

Study Arms (2)

Mini-pool Intravenous Immunoglobulin (MP-IVIG)

EXPERIMENTAL

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.

Other: Mini-pool Intravenous Immunoglobulin (MP-IVIG)

plasmapheresis

EXPERIMENTAL

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.

Other: plasma exchange

Interventions

Mini-pool Intravenous Immunoglobulin (MP-IVIG) OTHER

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.

Mini-pool Intravenous Immunoglobulin (MP-IVIG)

plasma exchange OTHER

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.

Also known as: plasmapheresis

plasmapheresis

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patient has severe form of Guillain-Barré syndrome (GBS) according to GBS disability score
• Patient with renal impairment
• Patient with hepatic cell failure

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• van Doorn PA, Ruts L, Jacobs BC. Clinical features, pathogenesis, and treatment of Guillain-Barre syndrome. Lancet Neurol. 2008 Oct;7(10):939-50. doi: 10.1016/S1474-4422(08)70215-1.

  PMID: 18848313 BACKGROUND

• El-Ekiaby M, Vargas M, Sayed M, Gorgy G, Goubran H, Radosevic M, Burnouf T. Minipool caprylic acid fractionation of plasma using disposable equipment: a practical method to enhance immunoglobulin supply in developing countries. PLoS Negl Trop Dis. 2015 Feb 26;9(2):e0003501. doi: 10.1371/journal.pntd.0003501. eCollection 2015 Feb.

  PMID: 25719558 BACKGROUND

• El-Ekiaby M, Sayed MA, Caron C, Burnouf S, El-Sharkawy N, Goubran H, Radosevich M, Goudemand J, Blum D, de Melo L, Soulie V, Adam J, Burnouf T. Solvent-detergent filtered (S/D-F) fresh frozen plasma and cryoprecipitate minipools prepared in a newly designed integral disposable processing bag system. Transfus Med. 2010 Feb;20(1):48-61. doi: 10.1111/j.1365-3148.2009.00963.x. Epub 2009 Sep 23.

  PMID: 19778318 BACKGROUND

• Winiecki S, Baer B, Chege W, Jankosky C, Mintz P, Baker M, Woodworth T, Nguyen M. Complementary use of passive surveillance and Mini-Sentinel to better characterize hemolysis after immune globulin. Transfusion. 2015 Jul;55 Suppl 2:S28-35. doi: 10.1111/trf.13116.

  PMID: 26174895 BACKGROUND

• Ojha R, Karn R(2019):Clinical outcome of intravenous immunoglobulin in the treatment of Guillain Barre Syndrome in a Nepalese tertiary centre. Nep Med J 2019;2(1):133-7.

  BACKGROUND

• Hughes RA, Cornblath DR. Guillain-Barre syndrome. Lancet. 2005 Nov 5;366(9497):1653-66. doi: 10.1016/S0140-6736(05)67665-9.

  PMID: 16271648 RESULT

MeSH Terms

Conditions

Guillain-Barre Syndrome

Interventions

Plasma Exchange; Plasmapheresis

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Maha A Mohamed, Prof

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Hend A Moubark, Specialist

CONTACT

01010326577; hindq1989@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical pathology specialist at assiut university hospitals blood banks

Model Details: 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 Central blood transfusions( CBTS) in Assiut University Hospital (AUH). The equipment used for the process comprised disposable blood bags, hemodialyzers, and purification and microbial filters.

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 16, 2020
• Study Start: November 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 14, 2021

Record last verified: 2020-09