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Efficacy and Safety and Pharmacokinetics of Boya IVIG

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

Last updated 2023-11-29

No results posted yet for this study

Summary

To evaluate the safety, efficacy and pharmacokinetic properties of Boya's IVIG preparation in participants with PID aged less than 60 years and more than 6 years.

Conditions

  • Primary Immunodeficiency Disease

Interventions

BIOLOGICAL

Boya IVIG

The initial dose and other dose changes will be determined by the investigator on a case-by-case basis aiming to prevent infection and minimum serum IgG levels of 5 g/L. The total number of doses administered will depend on the treatment regimen and run-in period: * Between 16 and 20 intravenous injections for participants receiving infusions every 28 days, or; * Between 21 and 25 intravenous injections for participants receiving infusions every 21 days

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
6 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-04-30
Completion
2025-09-30

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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