Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06089122
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-09-19
Brief Title:
Efficacy Safety and Pharmacokinetics of Shu Yang IVIG
Sponsor:
Azidus Brasil
Organization:
Azidus Brasil
Study Overview
Official Title:
Efficacy Safety and Pharmacokinetics of Shu Yang IVIG in Patients With Primary Immunodeficiency
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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:
Imunoforte
Brief Summary:
To evaluate the safety efficacy and pharmacokinetic properties of Shu Yang intravenous immune globulin in patients with primary immune deficiency aged less than 60 years
The main benefit of IVIG is to help the body fight against a large variety of infections generally associated with morbidity and mortality in patients with primary immunodeficiency diseases particularly in CVID and XLA In addition a decrease in the number of infections a reduction in medications and hospitalizations and a better quality of life are expected
Throughout treatment approximately one-fourth of persons may experience a side effect These are usually mild or bothersome but not dangerous Very rarely more serious side effects like allergic reactions or low blood counts anemia can occur One of the most common side effects is headache Other side effects include chills fever flushing flu-like muscle pains or joint pains feeling tired nausea vomiting and rash For the most part these reactions typically happen with the first dose of IVIG or because change to a different brand of IVIG All IVIG products have similar warnings and contraindications such as the potential for renal failure thrombotic events aseptic meningitis hemolysis and anaphylactic reactions
The main benefit of IVIG is to help the body fight against a large variety of infections generally associated with morbidity and mortality in patients with primary immunodeficiency diseases particularly in CVID and XLA In addition a decrease in the number of infections a reduction in medications and hospitalizations and a better quality of life are expected
Throughout treatment approximately one-fourth of persons may experience a side effect These are usually mild or bothersome but not dangerous Very rarely more serious side effects like allergic reactions or low blood counts anemia can occur One of the most common side effects is headache Other side effects include chills fever flushing flu-like muscle pains or joint pains feeling tired nausea vomiting and rash For the most part these reactions typically happen with the first dose of IVIG or because change to a different brand of IVIG All IVIG products have similar warnings and contraindications such as the potential for renal failure thrombotic events aseptic meningitis hemolysis and anaphylactic reactions
Detailed Description:
This is a Phase III open-label prospective single-arm multicenter trial to evaluate the efficacy of IVIG in maintaining the average of severe bacterial infections in less than one per year The safety and pharmacokinetics PK of the investigational product will also be evaluated Fifty male or female patients aged up to 60 years old will be selected At least 20 patients must be up to 17 years old During the trial at least 20 adult patients will be invited to make up the PK assessment subgroups
After obtaining the signed Informed ConsentAssent Form the screening procedures will be performed including the immune deficiency history from the medical records and safety exams Patients will start the trial with a run-in period to stabilize the IgG trough levels This period could last two to six visits with posological adjustments until the last two IgG trough levels are above 4 5 gL
After the run-in the one-year test period will start at the V0 Depending on the treatment regimen the patients will receive IVIG every 21 days 3 days up to day 378 or every 28 days 4 days up to day 364 when the close-out visit will occur In all visits from all patients a blood sample will be collected immediately before each IVIG administration to assess the IgG trough levels
To assess the investigational product PK properties a group of 20 patients will collect additional blood samples for dosing IgG levels between Visit 4 and Visit 5 Those taking IVIG every 21 days will collect six additional blood samples at the following times after the injection 30 min 2h 24h 72h 7 days and 14 days Those taking IVIG every 28 days will collect seven additional blood samples at the times 30 min 2h 24h 72h 7 days 14 days and 21 days
Adverse events will be collected at all visits to fulfill the safety endpoints Moreover the patients will have continuous access to the investigators team to report adverse events be instructed about how to proceed or even perform Extra visits for presential medical evaluation
Additionally the patient will receive a diary to record AEs any medication taken infections of any kind days of hospitalization and days missed from major activities due to infections
Trial duration Each patient can participate in the trial for a maximum period of approximately 540 days from the time of signing the ICF or IAF until the close-out visit including a Run-in period depending on treatment regimen
Blinding and Randomization This is an open-label trial no blinding and randomization procedures will be applied
After obtaining the signed Informed ConsentAssent Form the screening procedures will be performed including the immune deficiency history from the medical records and safety exams Patients will start the trial with a run-in period to stabilize the IgG trough levels This period could last two to six visits with posological adjustments until the last two IgG trough levels are above 4 5 gL
After the run-in the one-year test period will start at the V0 Depending on the treatment regimen the patients will receive IVIG every 21 days 3 days up to day 378 or every 28 days 4 days up to day 364 when the close-out visit will occur In all visits from all patients a blood sample will be collected immediately before each IVIG administration to assess the IgG trough levels
To assess the investigational product PK properties a group of 20 patients will collect additional blood samples for dosing IgG levels between Visit 4 and Visit 5 Those taking IVIG every 21 days will collect six additional blood samples at the following times after the injection 30 min 2h 24h 72h 7 days and 14 days Those taking IVIG every 28 days will collect seven additional blood samples at the times 30 min 2h 24h 72h 7 days 14 days and 21 days
Adverse events will be collected at all visits to fulfill the safety endpoints Moreover the patients will have continuous access to the investigators team to report adverse events be instructed about how to proceed or even perform Extra visits for presential medical evaluation
Additionally the patient will receive a diary to record AEs any medication taken infections of any kind days of hospitalization and days missed from major activities due to infections
Trial duration Each patient can participate in the trial for a maximum period of approximately 540 days from the time of signing the ICF or IAF until the close-out visit including a Run-in period depending on treatment regimen
Blinding and Randomization This is an open-label trial no blinding and randomization procedures will be applied
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1298-7059 | OTHER | WHO | None |