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Minipooled-IVIG in Primary Immunodeficiency Disease

10. maj 2020 opdateret af: Alshaimaa Mokhtar Selim mohamed, Assiut University

Study of Safety and Efficacy of Mini-pool Intravenous Immunoglobulin (MP-IVIG) Prepared by Assiut University Hospital Blood Bank in Primary Immunodeficiency Patients

  1. study the pharmacokinetics of mini-pooled intravenous immunoglobulin( MP-IVIG)

  2. Study the safety and efficacy of a newly developed preparation of MP-IVIG in children with primary immunodeficiency (PID) :

    • 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
  3. Compare the efficacy of MP-IVIG to standard IVIG in children with primary immunodeficiency (PID).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Primary immunodeficiency diseases (PID) are a heterogeneous group of inherited disorders of the immune system, predisposing individuals to recurrent infections, allergy, autoimmunity, and malignancies. Clinical descriptions have already been made for more than 200 PIDs, for which over 150 forms of PID have been molecularly characterized .

A population prevalence of diagnosed PID in the United States at approximately 1 in 1,200 persons.

A part from local registration in some centres there is no national registry of PID in Egypt, and hence, the prevalence of these disorders in the investigator's population is still unknown .

An increasing number of PID are recognized, and effective treatments are possible. Early use of prophylactic antibiotics and replacement immunoglobulin can prevent significant end organ damage and improve long quality of life in these patients .

Immunoglobulin G (IgG) is an essential plasma derived medicine that is lacking in developing countries .IgG shortages leave immune deficient patients without treatment, exposing them to devastating recurrent infections from local pathogens. A simple and practical method for producing IgG from normal plasma collected in developing countries is needed to provide better, faster access to IgG for patients .

Magdy EL-Ekiaby, et al 2010 introduce the concept of small-scale ("minipool") plasma processing methods 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 as well as minipool S/D-F cryoprecipitate to treat bleeding disorders.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

15

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Egypten
      • Assiut, Egypten
        • Faculty of Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: minipooled- Intravenous immunoglobulin(MP-IVIG)
• 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.
Andet: minipooled- 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Efficacy of MP-IVIG assessed by the incidence of acute Serious Bacterial infections(SBIs)
Tidsramme: 1 year
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
Tidsramme: 72 hour after adminstration of MP-IVIG and betwen 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 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
Tidsramme: predose sample

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
Tidsramme: (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
(1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose
Study the pharmacokinetics MP-IVIG half-life
Tidsramme: (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
(1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose
Study the pharmacokinetics MP-IVIG area under the curve
Tidsramme: (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
(1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose
Study the pharmacokinetics MP-IVIG Cmax
Tidsramme: (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
(1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose
Study the pharmacokinetics of MP-IVIG-Tmax.
Tidsramme: (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
(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).
Tidsramme: (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
(1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days) post-dose

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Compare efficacy of MP-IVIG vs standard IVIG by compare incidence of SBIs of both
Tidsramme: 1 year
• Compare the efficacy of MP-IVIG to standard IVIG in children with Primary immunodeficiency disease (PID).
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Assiut University

Efterforskere

  • Studieleder: Maha A Mohammed, professor, Assiut University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2020

Primær færdiggørelse (Faktiske)

1. maj 2020

Studieafslutning (Faktiske)

1. maj 2020

Datoer for studieregistrering

Først indsendt

26. marts 2019

Først indsendt, der opfyldte QC-kriterier

28. marts 2019

Først opslået (Faktiske)

1. april 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. maj 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. maj 2020

Sidst verificeret

1. maj 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IVIG in PID

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