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Primary ImmunodeficiencyNCT03896932

Minipooled-IVIG in Primary Immunodeficiency Disease

A study testing minipooled- Intravenous immunoglobulin(MP-IVIG) in people with Primary Immunodeficiency, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Primary Immunodeficiency
What is being tested?
minipooled- Intravenous immunoglobulin(MP-IVIG)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteEgypt
Study dates
1 Jan 2020to 1 May 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of Medicine

    Asyut

Other trials in Egypt

About this study

Official title: 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
  1. Compare the efficacy of MP-IVIG to standard IVIG in children with primary immunodeficiency (PID).
Read the detailed description

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.

Being tested
minipooled- Intravenous immunoglobulin(MP-IVIG)
Medical subject headings
Primary Immunodeficiency Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03896932
Study groupRoleWhat they receive
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.
Receives: Other: minipooled- Intravenous immunoglobulin(MP-IVIG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 year

  2. 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.

    Measured: 72 hour after adminstration of MP-IVIG and betwen infusions period

  3. Study the pharmacokinetics- MP-IVIG trough levels

    MP-IVIG trough level concentration values of serum total IgG pre the MP-IVIG infusion

    (if applicable).

    Measured: predose sample

  4. 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

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

  5. Study the pharmacokinetics MP-IVIG half-life

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

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

  6. Study the pharmacokinetics MP-IVIG area under the curve

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

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

  7. Study the pharmacokinetics MP-IVIG Cmax

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

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

  8. Study the pharmacokinetics of MP-IVIG-Tmax.

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

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

  9. 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

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

Secondary outcomes (1)

  1. Compare efficacy of MP-IVIG vs standard IVIG by compare incidence of SBIs of both

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2019
  2. Study start1 Jan 2020
  3. Primary completion1 May 2020
  4. Study completion1 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single Group Assignment
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03896932
Sponsor's protocol ID
IVIG in PID
Status last verified
May 2020
First submitted
26 Mar 2019
Last updated
12 May 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 19778318

  • 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.

    PubMed 17577648

  • 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.

    PubMed 19002574

  • 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.

    PubMed 18241226

Questions about this trial

What is this clinical trial studying?

A study testing minipooled- Intravenous immunoglobulin(MP-IVIG) in people with Primary Immunodeficiency, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of MP-IVIG assessed by the incidence of acute Serious Bacterial infections(SBIs) (time frame: 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03896932, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.

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