after you join the study, you are randomly assigned to receive either the active medication or a placebo. the assignment is double‑blind, meaning neither you nor the study staff know which one you receive.

the active medication is panzyga 100 mg/ml infusion solution. the placebo is isotone saline solution.

before the first infusion, a series of checks are performed, including physical examination, laboratory tests, and confirmation of your medical condition (low antibody levels, known as hypogammaglobulinemia, and treatment with b‑cell depletion therapy).

the results create a reference point for later safety and effectiveness evaluations.

you receive an intravenous infusion of the assigned product. the dose is 4 ml per kilogram of body weight, delivered through a vein.

the infusion is performed in a clinical setting where vital signs are monitored before, during, and after the procedure.

additional infusions of the same product are given at each scheduled visit according to the study protocol. each infusion uses the same dose of 4 ml per kilogram and follows the same safety monitoring procedures.

the exact timing of these visits is defined by the study schedule, which continues for the duration of the trial.

at each visit you undergo physical examinations and laboratory tests to check for any side effects or changes in health.

any new symptoms, especially signs of infection, are recorded and evaluated by an independent committee.

throughout the study you are asked to report any illness that could be a major infection. a major infection is defined as a serious infection that may require hospitalization or lead to death.

each reported infection is reviewed to determine its type, severity, and the time it takes to resolve.

at the end of the study period, a final set of examinations and laboratory tests is performed.

the data collected from all visits are used to evaluate the benefit of the active medication compared with the placebo for preventing major infections.