A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency
Public ClinicalTrials.gov record NCT04566692. 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 Multi-center, Single-Sequence, Open-label Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Subjects and Loading/Maintenance Dosing in Treatment-Naïve Subjects With Primary Immunodeficiency
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study is to determine whether biweekly (every 2 weeks) administration of Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) produces a steady-state area under the concentration versus time curve (AUC) of total Immunoglobulin G (IgG) that is non-inferior to that produced by weekly administration of IGSC 20% in treatment-experienced participants with primary immunodeficiency (PI).
Study identification
- NCT ID
- NCT04566692
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 33 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 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
- Nov 24, 2020 (Actual)
- Primary completion
- Jul 18, 2022 (Actual)
- Completion
- Jul 25, 2022 (Actual)
- Last update posted
- Sep 29, 2023
2020 – 2022
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Center of Alabama | Birmingham | Alabama | 35209 | — |
| Research Solutions of Arizona, PC | Litchfield Park | Arizona | 85340 | — |
| Allergy Associates of The Palm Beaches | North Palm Beach | Florida | 33408 | — |
| Allergy & Asthma Clinics of Georgia, P.C. | Albany | Georgia | 31707 | — |
| Institute for Asthma and Allergy | Chevy Chase | Maryland | 20815 | — |
| Washington University School of Medicine | St Louis | Missouri | 63141 | — |
| Optimed Research LTD | Columbus | Ohio | 43235 | — |
| Allergy, Asthma and Clinical Research Center | Oklahoma City | Oklahoma | 73120 | — |
| Oklahoma Institute of Allergy and Asthma Clinical Research | Oklahoma City | Oklahoma | 73131 | — |
| Vital Prospect Clinical Research Institute | Tulsa | Oklahoma | 74136 | — |
| Allergy and Clinical Immunology Associates | Pittsburgh | Pennsylvania | 15241 | — |
| 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 NCT04566692, 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 Sep 29, 2023 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04566692 live on ClinicalTrials.gov.