Trials / Completed
CompletedNCT03961009
Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients
A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety and Pharmacokinetics of Kedrion Intravenous Immunoglobulin (IVIg) 10% in Primary Immunodeficiency Disease (PID) Patients
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 47 (actual)
- Sponsor
- Kedrion S.p.A. · Industry
- Sex
- All
- Age
- 2 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to assess efficacy and safety of Kedrion Immunoglobulin 10% (KIg10) in participants with Primary Immunodeficiency (PID).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Kedrion IVIG 10% | Kedrion intravenous immunoglobulin (IVIg) 10% |
Timeline
- Start date
- 2019-04-30
- Primary completion
- 2020-12-21
- Completion
- 2020-12-21
- First posted
- 2019-05-23
- Last updated
- 2025-04-13
- Results posted
- 2022-01-27
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03961009. Inclusion in this directory is not an endorsement.