Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency
Public ClinicalTrials.gov record NCT02604810. 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
An Open-label, Multi-center Study to Evaluate the Safety and Pharmacokinetics of IGSC 20% Administered for 6 Months in Subjects With Primary Immunodeficiency
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study was designed to determine a dose of weekly subcutaneously administered Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (Grifols) (IGSC 20%) that produces steady-state AUC of total IgG that was non-inferior to that of the regularly administered intravenous dose of Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified (Grifols) (IGIV-C 10%) in primary immunodeficiency subjects. This study was also designed to determine steady state trough total IgG levels after IGSC 20% infusion and after IGIV-C 10% infusion for comparison and to assess the safety and tolerability of IGSC 20%.
Study identification
- NCT ID
- NCT02604810
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 53 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 75 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
- Jan 2016 (Actual)
- Primary completion
- Sep 2017 (Actual)
- Completion
- Dec 2017 (Actual)
- Last update posted
- Oct 4, 2019
2016 – 2017
United States locations
- U.S. sites
- 20
- U.S. states
- 14
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Medical Center | Los Angeles | California | 90095 | — |
| AIRE Medical of Los Angeles | Santa Monica | California | 90404 | — |
| National Jewish Health | Denver | Colorado | 80206 | — |
| University of Miami - Batchelor Children's Research Institute | Miami | Florida | 33136 | — |
| Allergy Associates of The Palm Beaches, PA | North Palm Beach | Florida | 33408 | — |
| University of South Florida | St. Petersburg | Florida | 33701 | — |
| Emory Children's Center | Atlanta | Georgia | 30322 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| The South Bend Clinic | South Bend | Indiana | 46617 | — |
| Children's Hospital of Michigan - Wayne State University | Detroit | Michigan | 48201 | — |
| Midwest Immunology | Plymouth | Minnesota | 55446 | — |
| Washington University Medical Center | St Louis | Missouri | 63110 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Oklahoma Institute of Allergy and Asthma Clinical Research | Oklahoma City | Oklahoma | 73131 | — |
| Vital Prospects Clinical Research Institute, PC | Tulsa | Oklahoma | 74136 | — |
| Penn State University | Hershey | Pennsylvania | 17033 | — |
| AARA Research Center | Dallas | Texas | 75231 | — |
| Baylor Texas Children's Hospital | Houston | Texas | 77030 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| Children's Hospital of Richmond at VCU, VCU Medical Center | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02604810, 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 Oct 4, 2019 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02604810 live on ClinicalTrials.gov.