Protocol summary
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Study aim
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Comparison of the effects and side effects of MedVac IVIg injection with Biotest IVIg among patients with Primary Immunodeficiency (PID) referred to Hazrat Rasoul Akram Hospital and Mofid Children's Hospital in Tehran
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Design
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Randomized, Open label, Cross-over, Clinical trial
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Settings and conduct
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Eligible PID patients after recruiting to the trial, in Mofid Children's Hospital and Hazrat Rasool Akram Hospital in Tehran, 25 patients in each arm, will be subjected to intervention by one of the two types of IVIg and followed for 4 weeks, after the end of the treatment period and completion of Wash out period, enters the opposite arm in a cross-sectional way and will receive the alternative type of IVIg and will be followed up for another 4 weeks.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria:
1- 2-40 years old patients with PID who weigh 10 kg or more and have received at least 6 months of IVIg the recruitment
2- Willingness to cooperate and obtain written consent
Exclusion Criteria:
1- Patients with secondary immunodeficiency, newly diagnosed PID and without treatment, dysglobunemia, IgA deficiency, HIV, hepatitis A,B,C or a history of these diseases
2 -History of hypersensitivity to IVIg or other forms of Ig or history of thrombotic complications of IVIg / History of severe seizures, migraines and DVT
3- Concomitant use of corticosteroids, chemotherapy, immunosuppressive drugs
4- Chronic kidney and liver diseases, Nephrotic syndrome and various malignancies
5- Acute bacterial infection in the last 7 days
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Intervention groups
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Infusion of 600 mg/kg IVIg produced by MedVac and Biotest every 4 weeks
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Main outcome variables
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Serum IgG level changes before and one hour after IVIg injection
General information
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Reason for update
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According to the opinions of the Clinical Studies Committee of the Food and Drug Organization, minor amendments have been made to the protocol and the Ethics Committees in the Research have been notified.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20101012004920N9
Registration date:
2021-02-23, 1399/12/05
Registration timing:
prospective
Last update:
2021-08-01, 1400/05/10
Update count:
1
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Registration date
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2021-02-23, 1399/12/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-09-01, 1400/06/10
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Expected recruitment end date
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2022-08-31, 1401/06/09
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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)
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Public title
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Evaluation of the effect of Medvac IVIg on PID
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 2 years old to 40 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Crossover
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-02-17, 1399/11/29
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Ethics committee reference number
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IR.IUMS.REC.1399.1285
2
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Ethics committee
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Approval date
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2021-03-01, 1399/12/11
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Ethics committee reference number
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IR.SBMU.RICH.EC.1400.008
Health conditions studied
1
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Description of health condition studied
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Primary immunodeficiency disorder
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ICD-10 code
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D84.9
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ICD-10 code description
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D84.9 is a billable/specific ICD-10-CM code that can be used to indicate a diagnosis for reimbursement purposes.
Primary outcomes
1
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Description
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Serum IgG level changes before and after IVIg injection
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Timepoint
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Before intervention and one hour after intervention
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Method of measurement
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ELISA serum IgG level measurement kit
Secondary outcomes
1
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Description
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Changes in serum IgG levels in the second week compared to the before of the intervention
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Timepoint
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Before intervention and the second week after intervention
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Method of measurement
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ELISA serum IgG level measurement kit
2
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Description
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Changes in serum IgG levels in the fourth week compared to the before of intervention
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Timepoint
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Before intervention and the fourth week after intervention
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Method of measurement
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ELISA serum IgG level measurement kit
3
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Description
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Changes in liver function tests in the fourth week compared to the before of intervention
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Timepoint
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Before intervention and the fourth week after intervention
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Method of measurement
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Aspartate aminotransferase, Alanine aminotransferase, Alkaline phosphatase and Bilirubin levels measurment kits
4
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Description
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Changes in renal tests in the fourth week compared to the before of intervention
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Timepoint
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Before intervention and the fourth week after intervention
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Method of measurement
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Blood Urea Nitrogen and Creatinine levels measurement kits
5
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Description
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Changes in blood cell count in the fourth week compared to the before of intervention
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Timepoint
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Before intervention and the fourth week after intervention
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Method of measurement
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Automated hematology analyzer
6
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Description
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Changes in inflammatory factors in the fourth week compared to the before of intervention
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Timepoint
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Before intervention and the fourth week after intervention
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Method of measurement
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Westergren method for Erythrocyte Sedimentation Rate, ELISA kit for C-reactive protein measurement
7
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Description
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Incidence and severity of acute bacterial infections
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Timepoint
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During the study
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Method of measurement
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Microscopic observation (Gram staining), phenotypic study of bacterial properties based on cell culture media, detection of antibodies against bacterial structures with the serological methods
8
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Description
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The rate of possible adverse reactions
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Timepoint
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During the study
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Method of measurement
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Clinical examination and patient history
9
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Description
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The incidence of death during the study
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Timepoint
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During the study
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Method of measurement
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Clinical examination
Intervention groups
1
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Description
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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
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Category
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Treatment - Drugs
2
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Description
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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
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Medvac BioPharma Company
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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After publishing a scientific article and for 5 years
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To whom data/document is available
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Researchers in the field of medicine and health
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Under which criteria data/document could be used
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By submitting a scientific proposalو approval of the ethics committee and after the written consent of MedVac BioPharma Company
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From where data/document is obtainable
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Principle investigators of the trial
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What processes are involved for a request to access data/document
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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
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Comments
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