Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients
Public ClinicalTrials.gov record NCT03961009. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study was to assess efficacy and safety of Kedrion Immunoglobulin 10% (KIg10) in participants with Primary Immunodeficiency (PID).
Study identification
- NCT ID
- NCT03961009
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 47 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 29, 2019
- Primary completion
- Dec 20, 2020
- Completion
- Dec 20, 2020
- Last update posted
- May 4, 2026
2019 – 2020
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Allergy Associates of the Palm Beaches | North Palm Beach | Florida | 33408 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Dr. Henry J. Kanarek - Allergy, Asthma & Immunology | Overland Park | Kansas | 66211 | — |
| Midwest Immunology Clinic and Infusion Center | Plymouth | Minnesota | 55446 | — |
| Allergy and Immunology Associates | Little Silver | New Jersey | 07739 | — |
| University of Buffalo | Buffalo | New York | 14203 | — |
| Optimed Research | Columbus | Ohio | 43235 | — |
| Ohio Clinical Research Associates, Inc. | Mayfield Heights | Ohio | 44124 | — |
| Toledo Institute of Clinical Research Inc | Toledo | Ohio | 43617 | — |
| Allergy Partners of North Texas Research | Dallas | Texas | 75230 | — |
| AARA Research Center | Dallas | Texas | 75231 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03961009, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 4, 2026 · Synced Sep 27, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03961009 live on ClinicalTrials.gov.