Efficacy and Safety and Pharmacokinetics of Boya IVIG

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

April 30, 2025

Study Completion Date

September 30, 2025

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
All Listed Sponsors
collaborator

Boya Bio Pharmaceutical Group Co Ltd

UNKNOWN

lead

Azidus Brasil

INDUSTRY

NCT06150833 - Efficacy and Safety and Pharmacokinetics of Boya IVIG | Biotech Hunter | Biotech Hunter