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Minipooled-IVIG in Primary Immunodeficiency Disease

NCT03896932 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-05-12

No results posted yet for this study

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).

Conditions

  • Primary Immunodeficiency

Interventions

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.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Maha A Mohammed, professor · Assiut University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2020-05-01
Completion
2020-05-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03896932 on ClinicalTrials.gov