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.
Who can participate
Age range
2 Years – 60 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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:
. 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.
. Any active or resolved cancer in the last 12 months before screening.