drugset / Trial / NCT04944979

Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients (KIDCARES10)

NCT04944979 ↗

Phase 3 Active not recruiting 30 enrolled Kedrion S.p.A.
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess efficacy, safety and pharmacokinetics of Kedrion Immunoglobulin 10% (KIg10) in pediatric patients with Primary Immunodeficiency Disease (PID).

Timeline

Start
2021-03-31
Primary completion
2026-12
Completion
2027-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Kedrion IVIG Protein / enzyme biologic 200 mg/kg Intravenous
Subject Kedrion IVIG Protein / enzyme biologic 800 mg/kg Intravenous