IVIG Boya: Safety, Efficacy, and Pharmacokinetics
Starting soon · Phase 3
Conditions studied: Primary Immunodeficiency Disease
In brief
The goal of this phase 3, open-label, single-group clinical trial is to assess the efficacy of Boya IVIG in maintaining the mean number of serious bacterial infections to less than one per year in participants with primary immunodeficiency (PYD) due to common variable immunodeficiency (CVID), as defined by the European Immunodeficiency Society (ESCID) / Pan American Immunodeficiency Group (PAGID), or X-linked agammaglobulinemia (XLA), as defined by molecular genetic testing (ESCID/PAGID). The safety and pharmacokinetics (PK) of the investigational product will also be evaluated. Participants must: * Visit the research center every 21 or 28 days to receive the experimental product infusion and undergo a medical examination. * During weekly telephone calls, report, if applicable, adverse events and hospitalizations; the number of school or workdays missed due to infections; the length of hospital stay; and the use of antibiotics for therapeutic purposes.
Key facts
- Study ID
- NCT06150833
- Run by
- Azidus Brasil
- People needed
- 50
- Starts
- 2026-09-01
- Expected to finish
- 2028-09-01
- Last updated by the study team
- 2026-06-03
Who can join
Age: 2 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Men or women; age between 02 and 60 years; written informed consent/assent.
- Diagnosis of primary immunodeficiency disease (PID) with decreased antibody production due to common variable immunodeficiency (CVID) or X-linked agammaglobulinemia (XLA).
- Treatment-naïve patients and those receiving intravenous immunoglobulin replacement therapy at 21- to 28-day intervals, with doses ranging from 300 to 800 mg/kg per infusion.
- Negative pregnancy test in females of childbearing potential; willingness to use effective contraceptive methods throughout the study.
- Subjects currently receiving any subcutaneous or intramuscular immunoglobulin may be enrolled by switching to IVIG therapy at the investigator's discretion, considering the potential benefit to the participant.
- Exclusion Criteria Patients who meet any of the following criteria will be disqualified from participating.
- Known intolerance or hypersensitivity to immunoglobulins or components of the study drug.
- Any contraindications to the use of immunoglobulins.
- Patients with a BMI < 18.5 or > 40 kg/m2.
- Secondary immunodeficiency or clinical conditions that potentially cause secondary immunodeficiency, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, enteropathies, or nephropathies with protein loss and hypoalbuminemia.
- Clinically significant changes in safety assessments, defined as:
- Blood count
- Hb < 10,5 g/dL
- Leukocytes < 3,000 cells/mm3 or > 11,000 cells/mm3
- Absolute neutrophil count < 1,000 cells/mm3
- Coagulation:
- o PT and aPTT> 2,5 x ULN.
- Biochemistry:
- glycated hemoglobin > 6.5%
- total bilirubin and fractions, alkaline phosphatase, ALT, AST, GGT > 2.5 x ULN
- creatinine above 3mg/dL or creatinine clearance <30mL/min
- Urine I:
- Clinically significant leukocyturia at the discretion of the investigator.
- History of serious bacterial infections within three months before screening, presence of an active infection at the time of inclusion, and failure to fully resolve any non-serious infection at least two weeks before screening.
- Any febrile illness in the 14 days before inclusion.
Full record on ClinicalTrials.gov
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