Minipooled-IVIG in Primary Immunodeficiency Disease

NCT03896932 | Completed

• 1 other identifier: IVIG in PID
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

• Adverse reaction of MP-IVIG(anaphylaxis and haemolysis)( no or mild or moderate)
• Prevention of severe bacterial infection
• Improvement of general health(weight gain and mentality)
• Integration in to social live
• Compare the efficacy of MP-IVIG to standard IVIG in children with primary immunodeficiency (PID).

Conditions

Primary Immunodeficiency

Outcome Measures

Primary Outcomes (9)

• Efficacy of MP-IVIG assessed by the incidence of acute Serious Bacterial infections(SBIs)

  The rate of Acute SBIs for each participant per 1 year will be assessed by questionnaire (Serious Bacterial Infections) include sign and symptoms of acute serious bacterial infections, i.e. bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, osteomyelitis/ septic arthritis, visceral abscess.

  1 year

• Safty of MP-IVIG assessed by 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 temprature 2)Hemolysis by hemoglobin level,LDH,billirubin level.2)lbetwen infusions by home diaries.

  72 hour after adminstration of MP-IVIG and betwen 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

  (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 efficacy of MP-IVIG vs standard IVIG by compare incidence of SBIs of both

  1 year

Study Arms (1)

minipooled- Intravenous immunoglobulin(MP-IVIG)

EXPERIMENTAL

• MP-IVIG equivalent to 1 g/ kg of standard IVIG over a 6-hour to 8-hour period monthly alternated by standard IVIG for a period of 12 months follow up and the newly diagnosed cases admitted to AUH in the follow up period will be included.

Other: minipooled- Intravenous immunoglobulin(MP-IVIG)

Interventions

minipooled- 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.

minipooled- Intravenous immunoglobulin(MP-IVIG)

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age group: children patients under 18 years.
• The study will include patient diagnosed as primary immunodeficiency disease (PID) in Assiut university hospital on standard IVIG therapy.

You may not qualify if:

• Patient has SCID.
• Patient with history of severe IVIG side effect.
• Patient with severe immunodeficiency and has severe disseminated infection.
• Patient with renal impairment
• Patient with hepatic cell failure
• Patient with endocrinal abnormalities
• patient with secondary immunodeficiency diseases

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine

Asyut, Egypt

Location

Related Publications (4)

• 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

• Boyle JM, Buckley RH. Population prevalence of diagnosed primary immunodeficiency diseases in the United States. J Clin Immunol. 2007 Sep;27(5):497-502. doi: 10.1007/s10875-007-9103-1. Epub 2007 Jun 19.

  PMID: 17577648 BACKGROUND

• Reda SM, Afifi HM, Amine MM. Primary immunodeficiency diseases in Egyptian children: a single-center study. J Clin Immunol. 2009 May;29(3):343-51. doi: 10.1007/s10875-008-9260-x. Epub 2008 Nov 11.

  PMID: 19002574 BACKGROUND

• Piguet D, Tosi C, Luthi JM, Andresen I, Juge O; Study investigators. Redimune NF Liquid, a ready-to-use, high-concentration intravenous immunoglobulin therapy preparation, is safe and typically well tolerated in the routine clinical management of a broad range of conditions. Clin Exp Immunol. 2008 Apr;152(1):45-9. doi: 10.1111/j.1365-2249.2008.03597.x. Epub 2008 Jan 28.

  PMID: 18241226 BACKGROUND

Related Links

• Gathmann B, Grimbacher B, Beauté J, Dudoit Y, Mahlaoui N, Fischer A(2009):. ESID Registry Working Party. The European internet based patient and research database for primary immunodeficiency: results 2006-2008. Clin Exp Immuno.

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Maha A Mohammed, professor

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 1, 2019
• Study Start: January 1, 2020
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: May 12, 2020

Record last verified: 2020-05

Locations

EG (1)