Trials / Active Not Recruiting
Active Not RecruitingNCT04944979
Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in Pediatric PID Patients (KIDCARES10)
A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety, and Pharmacokinetics of Kedrion Intravenous Human Normal Immunoglobulin (IVIg) 10% in Pediatric Patients Affected by Primary Immunodeficiency Disease (PID)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Kedrion S.p.A. · Industry
- Sex
- All
- Age
- 2 Years – 16 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Kedrion IVIG 10% | Kedrion intravenous immunoglobulin (IVIg) 10% |
Timeline
- Start date
- 2021-03-31
- Primary completion
- 2026-04-30
- Completion
- 2026-10-30
- First posted
- 2021-06-30
- Last updated
- 2026-01-15
Locations
21 sites across 6 countries: United States, Hungary, Italy, Portugal, Russia, Slovakia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04944979. Inclusion in this directory is not an endorsement.