Primary immunodeficiency disorder. D84.9 is a billable/specific ICD-10-CM code that can be used to indicate a diagnosis for reimbursement purposes.
Conditions
Interventions
Intervention 1: Intravenous infusion of human polyclonal antibody (IVIg) produced by MedVac BioPharma Company at a dose of 600 milligram per kilogram of body weight in a single dose. Intervention 2: I
Sponsors
Medvac BioPharma Company
Eligibility
Sex/Gender
All
Age
2 Years to 40 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in serum IgG levels in the second week compared to the before of the intervention. Timepoint: Before intervention and the second week after intervention. Method of measurement: ELISA serum IgG level measurement kit.;Changes in serum IgG levels in the fourth week compared to the before of intervention. Timepoint: Before intervention and the fourth week after intervention. Method of measurement: ELISA serum IgG level measurement kit.;Changes in liver function tests in the fourth week compared to the before of intervention. Timepoint: Before intervention and the fourth week after intervention. Method of measurement: Aspartate aminotransferase, Alanine aminotransferase, Alkaline phosphatase and Bilirubin levels measurment kits.;Changes in renal tests in the fourth week compared to the before of intervention. Timepoint: Before intervention and the fourth week after intervention. Method of measurement: Blood Urea Nitrogen and Creatinine levels measurement kits.;Changes in blood cell count in the fourth week compared to the before of intervention. Timepoint: Before intervention and the fourth week after intervention. Method of measurement: Automated hematology analyzer.;Changes in inflammatory factors in the fourth week compared to the before of intervention. Timepoint: Before intervention and the fourth week after intervention. Method of measurement: Westergren method for Erythrocyte Sedimentation Rate, ELISA kit for C-reactive protein measurement.;Incidence and severity of acute bacterial infections. Timepoint: During the study. Method of measurement: Microscopic observation (Gram staining), phenotypic study of bacterial properties based on cell culture media, detection of antibodies against bacterial structures with the serological methods.;The rate of possible adverse reactions. Timepoint: During the study. Method of measurement: Clinical examination and patient history.;The incidence of death during the study. Timepoint: During the study. Method of measurement | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Gita Shafiee
Tehran University of Medical Sciences
Outcome results
None listed