Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06150833
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-29
First Post:
2023-11-21
Brief Title:
Efficacy and Safety and Pharmacokinetics of Boya IVIG
Sponsor:
Azidus Brasil
Organization:
Azidus Brasil
Study Overview
Official Title:
Efficacy Safety and Pharmacokinetics of Boya Intravenous Immunoglobulin IVIG in Participants With Primary Immunodeficiency
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Boya
Brief Summary:
To evaluate the safety efficacy and pharmacokinetic properties of Boyas IVIG preparation in participants with PID aged less than 60 years and more than 6 years
Detailed Description:
This is a phase 3 open-label prospective single-group multicenter study to evaluate the efficacy of IVIG in keeping the average number of serious bacterial infections to less than one per year The safety and pharmacokinetics PK of the investigational product will also be assessed Fifty male or female participants aged up to 60 years will be selected with at least 20 participants aged between 06 and 17 years During the study at least 20 adult participants will be invited to make up the subgroups evaluating the pharmacokinetic parameters
The main benefit of IVIG is to help the immune system respond to a wide range of infections which are often correlated with high morbidity and mortality rates in individuals with PID particularly in cases of CVID and XLA In addition a reduction in the use of medication and hospitalizations is expected promoting an improvement in the quality of life of these patients
IVIG therapy is generally safe although unwanted effects are reported in a proportion ranging from 1 to 81 of patients or infusions with an average incidence of 30 to 40 among patients and 5 to 15 among infusions These effects can manifest themselves in varying degrees of intensity ranging from mild to severe They can occur immediately during or shortly after the infusion as well as late appearing hours or even days after the procedure Most adverse events are mild and immediate occurring in the first few infusions related to the infusion rate and quickly reversible
Headache fever general malaise flu-like symptoms nausea chills fatigue myalgia low back pain tachycardia changes in blood pressure and erythroderma are the most common events Serious reactions occur in less than 1 of applications and usually with the use of higher doses indicated in autoimmune and inflammatory diseases
Special care is needed in patients with comorbidities such as heart disease nephropathy liver disease coagulation disorders thrombophilia and diabetes mellitus In these patients certain characteristics of IVIG should be assessed such as the presence of sugars osmolality sodium among others
The main benefit of IVIG is to help the immune system respond to a wide range of infections which are often correlated with high morbidity and mortality rates in individuals with PID particularly in cases of CVID and XLA In addition a reduction in the use of medication and hospitalizations is expected promoting an improvement in the quality of life of these patients
IVIG therapy is generally safe although unwanted effects are reported in a proportion ranging from 1 to 81 of patients or infusions with an average incidence of 30 to 40 among patients and 5 to 15 among infusions These effects can manifest themselves in varying degrees of intensity ranging from mild to severe They can occur immediately during or shortly after the infusion as well as late appearing hours or even days after the procedure Most adverse events are mild and immediate occurring in the first few infusions related to the infusion rate and quickly reversible
Headache fever general malaise flu-like symptoms nausea chills fatigue myalgia low back pain tachycardia changes in blood pressure and erythroderma are the most common events Serious reactions occur in less than 1 of applications and usually with the use of higher doses indicated in autoimmune and inflammatory diseases
Special care is needed in patients with comorbidities such as heart disease nephropathy liver disease coagulation disorders thrombophilia and diabetes mellitus In these patients certain characteristics of IVIG should be assessed such as the presence of sugars osmolality sodium among others
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None