MedTrace Logo

IVIG Boya: Safety, Efficacy, and Pharmacokinetics

NCT06150833 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-06-03

No results posted yet for this study

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.

Conditions

  • Primary Immunodeficiency Disease

Interventions

BIOLOGICAL

Boya IVIG

Intervention: Biological: Boya IVIG Boya IVIG is a 5% human immunoglobulin for intravenous administration

Sponsors & Collaborators

  • Boya Bio Pharmaceutical Group Co Ltd

    collaborator UNKNOWN

  • Azidus Brasil

    lead INDUSTRY

Principal Investigators

  • Luciana Ferrara · Azidus Brasil

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-09-30
Completion
2028-09-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06150833 on ClinicalTrials.gov