Evaluation of the effect of Medvac IVIg on PID

Phase 3

• Conditions: Primary immunodeficiency disorder.; D84.9 is a billable/specific ICD-10-CM code that can be used to indicate a diagnosis for reimbursement purposes.; D84.9

• Registration Number: IRCT20101012004920N9
• Lead Sponsor: Medvac BioPharma Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients with congenital or primary immunodeficiency of 2-40years old who weigh 10 kg or more.
Previously confirmed Congenital or Primary Immunodeficiency which have received at least six months of IVIg treatment
Willingness to cooperate and obtain informed written consent from the patient, parent or legal guardian of the child

Exclusion Criteria

Patients with secondary immunodeficiency, newly diagnosed primary immunodeficiency and without treatment, dysglobunemia
History of hypersensitivity to IVIg or other injectable forms of Ig or history of thrombotic complications of IVIg treatment
Patients with IgA deficiency
Concomitant use of corticosteroids, chemotherapy, immunosuppressive drugs
Patients with HIV, hepatitis A, B, C or a history of these diseases
History of severe seizures or migraines
Chronic kidney diseases, liver and various malignancies
Nephrotic syndrome
DVT history
Acute bacterial infection in the last 7 days

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum IgG level changes before and after IVIg injection. Timepoint: Before intervention and one hour after intervention. Method of measurement: ELISA serum IgG level measurement kit.