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IRCT20101012004920N9 IRCT 2021-02-23 Medvac BioPharma Company Evaluation of the effect of Medvac IVIg on PID Evaluation of Efficacy and Possible Side Effects of Human Polyclonal Antibodies (IVIg) of Medvac Biopharma Co. in the Treatment of Patients with Primary Immunodeficiency disorder (PID) 2021-09-01 anticipated 50 Complete https://irct.ir/trial/52869 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: After selection of eligible patients and obtaining informed consent, a unique code will be assigned to each patient and randomized in two treatment groups. The randomization method will be Permuted Balanced Block Randomization. Blocks of 4 will be selected according to the number of intervention groups. 3 Primary immunodeficiency disorder. 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: Intravenous infusion of human polyclonal antibody (IVIg) produced by Biotest Company at a dose of 600 milligram per kilogram of body weight in a single dose. Yes - There is a plan to make this available What will be shared: After completion of the study, submission of the final report to the Ministry of Health and scientific article release, all unidentifiable patient data will be shared. When: After publishing a scientific article and for 5 years To whom: Researchers in the field of medicine and health Conditions: By submitting a scientific proposalو approval of the ethics committee and after the written consent of MedVac BioPharma Company Where to obtain: Principle investigators of the trial How to obtain: 1- Submitting a written request including the title of the research and the required variables along with the scientific proposal to one of the principle investigators and obtaining his written consent 2- Obtaining the written consent of MedVac BioPharma Company 3- Obtaining the approval of the ethics committee Comments:
public Dr. Gita Shafiee
No. 10, Jalal Al-e-Ahmad St., Chamran Hwy
Tehran Iran (Islamic Republic of) 1411713137 +98 21 8822 0086 gshafiee.endocrine@gmail.com Tehran University of Medical Sciences scientific Dr. Peyman Eshghi
Mofid Children Hospital, Shariati Ave
Tehran Iran (Islamic Republic of) 15468-15514 +98 21 2226 5488 p_eshghi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 2 years 40 years Both 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 D84.9 D84.9 is a billable/specific ICD-10-CM code that can be used to indicate a diagnosis for reimbursement purposes. Treatment - Drugs Treatment - Drugs 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 Intravenous infusion of human polyclonal antibody (IVIg) produced by Biotest Company at a dose of 600 milligram per kilogram of body weight in a single dose 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. 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: Clinical examination. Medvac BioPharma Company Approved 2021-02-17 Iran University of Medical Sciences Ethical Committee Hemmat Highway, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of) Approved 2021-03-01 Biomedical Research Ethics Committee, Research Instutute for Children Health, Shahid Beheshti Univer Mofid Hospital, Shariati St. Tehran Tehran Iran (Islamic Republic of)