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IVIG Boya: Safety, Efficacy, and Pharmacokinetics

Study acronym: BoyaIVIG
StatusNot Yet Recruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date: Apr 30, 2025 to Sep 2028v2 Show 8 more changesShow less
    • Start date: Apr 1, 2024 to Sep 2026
    • Primary endpoint revised
    • Study completion date: Sep 30, 2025 to Sep 2028
    • Eligibility criteria expanded, about 79 words
    • Secondary endpoints revised (4)
    • Study description expanded, about 226 words
    • Publications: 35 to 4
    • Study title shortened, about 2 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06150833
Lead Sponsor Azidus Brasil
Collaborators: Boya Bio Pharmaceutical Group Co Ltd
Conditions
(from sponsor)		 Primary Immunodeficiency Disease
Related terms Bruton type agammaglobulinemia, Common Variable Immunodeficiency, Primary Immunodeficiency Diseases
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov