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)
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
Design
Randomized, Open label, Cross-over, Clinical trial
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1- 2-40 years old patients with PID who weigh 10 kg or more and have received at least 3 courses 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 allergy 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
Intervention groups
Infusion of 0.4 mg/kg IVIg produced by MedVac and Biotest every 4 weeks
Main outcome variables
Serum IgG level changes before and after IVIg injection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101012004920N9
Registration date:2021-02-23, 1399/12/05
Registration timing:prospective
Last update:2021-02-23, 1399/12/05
Update count:1
Registration date
2021-02-23, 1399/12/05
Registrant information
Name
Ramin Heshmat
Name of organization / entity
Chronic Diseases Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0086
Email address
rheshmat@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-10, 1400/01/21
Expected recruitment end date
2021-07-11, 1400/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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)
Public title
Evaluation of the effect of Medvac IVIg on PID
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with congenital or primary immunodeficiency of 2-18 years old who weigh 10 kg or more.
Previously confirmed Congenital or Primary Immunodeficiency which have received at least three months of IVIg treatment
Willingness to cooperate and obtain informed written consent from the parent or legal guardian of the child
Exclusion criteria:
Patients with secondary immunodeficiency, newly diagnosed primary immunodeficiency and without treatment, dysglobunemia
History of allergy 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
Age
From 2 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences Ethical Committee
Street address
Hemmat Highway, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-02-17, 1399/11/29
Ethics committee reference number
IR.IUMS.REC.1399.1285
Health conditions studied
1
Description of health condition studied
Primary immunodeficiency disorder
ICD-10 code
D84.9
ICD-10 code description
D84.9 is a billable/specific ICD-10-CM code that can be used to indicate a diagnosis for reimbursement purposes.
Primary outcomes
1
Description
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 outcomes
1
Description
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
2
Description
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
3
Description
Changes in liver function tests in the fourth week compared to the before of intervention
Timepoint
Before intervention and the fourth week after intervention
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
5
Description
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
6
Description
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
7
Description
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
8
Description
The rate of possible adverse reactions
Timepoint
During the study
Method of measurement
Clinical examination and patient history
9
Description
The incidence of death during the study
Timepoint
During the study
Method of measurement
Clinical examination
Intervention groups
1
Description
Intravenous infusion of human polyclonal antibody (IVIg) produced by MedVac BioPharma Company at a dose of 0.4 milligram per kilogram of body weight in a single dose
Category
Treatment - Drugs
2
Description
Intravenous infusion of human polyclonal antibody (IVIg) produced by Biotest Company at a dose of 0.4 milligram per kilogram of body weight in a single dose
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid Children Hospital, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Peyman Eshghi
Street address
Shariati Street
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2226 5488
Email
p_eshghi@sbmu.ac.ir
2
Recruitment center
Name of recruitment center
Rasool Akram Hospital, Iran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Faranoush
Street address
Sattarkhan Ave., Niayesh St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6652 5328
Email
faranoush.m@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Medvac BioPharma Company
Full name of responsible person
Dr. Bardia Farzamfar
Street address
Phase 2 of the intersection of Golestan 9th and Mahestan St, Baharestan Industrial Town,5 km of Karaj-Qazvin Hwy
City
Karaj
Province
Alborz
Postal code
3197994599
Phone
+98 26 3476 0942
Email
info@medvac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medvac BioPharma Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Gita Shafiee
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
No. 10, Jalal Al-e-Ahmad St., Chamran Hwy
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 21 8822 0086
Email
gshafiee.endocrine@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Peyman Eshghi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Mofid Children Hospital, Shariati Ave
City
Tehran
Province
Tehran
Postal code
15468-15514
Phone
+98 21 2226 5488
Email
p_eshghi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Gita Shafiee
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
No. 10, Jalal Al-e-Ahmad St., Chamran Hwy
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 21 8822 0086
Email
gshafiee.endocrine@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
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 the data will become available and for how long
After publishing a scientific article and for 5 years
To whom data/document is available
Researchers in the field of medicine and health
Under which criteria data/document could be used
By submitting a scientific proposalو approval of the ethics committee and after the written consent of MedVac BioPharma Company
From where data/document is obtainable
Principle investigators of the trial
What processes are involved for a request to access data/document
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