A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Panzyga for Prevention of Major Infection in Patients with Hypogammaglobulinemia and Autoimmune or Rheumatic Conditions Receiving Treatment with B-cell Depletion Therapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
360
Panzyga is a 10% Ig formulation for intravenous (IV) administration
4 mL/kg 0.9% w/v sodium chloride solution per single IV infusion
Occurrence of Major Infections in Participants
Occurrence of at least one major infection or death in patients with or without primary infection prophylaxis with Panzyga during the treatment period. Each potential infection will be assessed by an Independent Adjudication Committee (IAC). Major infections will be defined as bacterial and/or viral infections, which are microbiologically documented or clinically documented requiring treatment with anti-infective, including those resulting in death, excluding confirmed cases of COVID-19.
Time frame: 48 weeks
Time to Major Infections in Participants
Time to first major infection (as assessed by the IAC) during the treatment period or death. The secondary safety endpoints of this study include the incidence of adverse events and changes from baseline in physical examinations and clinical laboratory parameters.
Time frame: 48 weeks
Number of Participants Experiencing AEs
Incidents of AEs during the treatment period
Time frame: 48 weeks
Participants Experiencing Changes from Baseline in Physical Examinations, and Clinical Laboratory Parameters
Changes from baseline in physical examination findings and clinical laboratory parameters will be assessed during the treatment period. Each parameter will be reported separately according to its unit of measure, such as body weight (kg), height (cm), body mass index (kg/m²), and individual laboratory values (e.g., hemoglobin \[g/dL\], serum creatinine \[mg/dL\]). Where applicable, related measurements (e.g., weight and height) will be combined to derive a single parameter, such as body mass index, to ensure consistent and interpretable results.
Time frame: 48 Weeks
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