Efficacy, Safety, and Pharmacokinetics of Shu Yang IVIG

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 30, 2024

Primary Completion Date

January 8, 2025

Study Completion Date

June 8, 2025

Conditions
Primary Immunodeficiency Disease
Interventions
BIOLOGICAL

IVIG

Patients with primary immunodeficiency will switch to Shu Yang IVIG and optimize the posology to IgG 300 to 600 mg every 21 or 28 days in a run-in period of 2 to 6 administrations, aiming at keeping the IgG trough levels above 5 g/L. At Visit 4, at least 20 patients will perform the PK assessment, collecting additional blood samples.

All Listed Sponsors
collaborator

Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd.

UNKNOWN

lead

Azidus Brasil

INDUSTRY