IVIG Boya: Safety, Efficacy, and Pharmacokinetics

Summary

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.

Timeline

Start

2026-09

Primary completion

2028-09

Completion

2028-09

Publications

• Background World Health Organization (2005) Recommendations for the production, control and regulation of human plasma for fractionation, Annex 4, TRS nº 941, pp. 69.
• Background EMA/CHMP/BPWP/94033/2007 rev. 4. Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg), Sep,2020.
• Background Brasil, Resolução nº 251, de 07 de agosto de 1977. Disponível em; https://www.inca.gov.br/sites/ufu.sti.inca.local/files//media/document//resolucao-cns-251-97.pdf. Acesso em 25 de out de 2023
• Background Food and Drug Administration (2006). Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees. Rockville, MD, pp. 38.

Drugs

Indications