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Minipooled-IVIG in Primary Immunodeficiency Disease

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ClinicalTrials.gov Identifier: NCT03896932
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Alshaimaa Mokhtar Selim mohamed, Assiut University

Brief 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 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).

Condition or disease Intervention/treatment Phase
Primary Immunodeficiency Other: minipooled- Intravenous immunoglobulin(MP-IVIG) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: 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.
Other: 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.




Primary Outcome Measures :
  1. Efficacy of MP-IVIG assessed by the incidence of acute Serious Bacterial infections(SBIs) [ Time Frame: 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.

  2. Safty of MP-IVIG assessed by percentage of adverse Events [ Time Frame: 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.

  3. Study the pharmacokinetics- MP-IVIG trough levels [ Time Frame: predose sample ]

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

    (if applicable).


  4. Study the pharmacokinetics MP-IVIG plasma concentration -time curve [ Time Frame: (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

  5. Study the pharmacokinetics MP-IVIG half-life [ Time Frame: (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

  6. Study the pharmacokinetics MP-IVIG area under the curve [ Time Frame: (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

  7. Study the pharmacokinetics MP-IVIG Cmax [ Time Frame: (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

  8. Study the pharmacokinetics of MP-IVIG-Tmax. [ Time Frame: (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

  9. Study the pharmacokinetics of MP-IVIG elimination rate constant(s). [ Time Frame: (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


Secondary Outcome Measures :
  1. Compare efficacy of MP-IVIG vs standard IVIG by compare incidence of SBIs of both [ Time Frame: 1 year ]
    • Compare the efficacy of MP-IVIG to standard IVIG in children with Primary immunodeficiency disease (PID).



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896932


Contacts
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Contact: Alshaimaa M Selim, specialist 01003580480 shaimaamokhtargood@yahoo.com
Contact: Taghreed M Kamal Eldin, professor 01006258668 ta_kamal55@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Maha A Mohammed, professor Assiut University

Additional Information:
Publications:
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Responsible Party: Alshaimaa Mokhtar Selim mohamed, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03896932    
Other Study ID Numbers: IVIG in PID
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs