A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency
Public ClinicalTrials.gov record NCT04561115. 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 3, Multicenter, Open-label, Single-sequence, Cross-over, Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of IVIG-PEG Compared to Gamunex-C in Subjects With Primary Humoral Immunodeficiency
Study identification
- NCT ID
- NCT04561115
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Grifols Therapeutics LLC
- Industry
- Enrollment
- 33 participants
Conditions and interventions
Conditions
Interventions
- Gamunex-C Biological
- IVIG-PEG Biological
Biological
Eligibility (public fields only)
- Age range
- 18 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
- Sep 1, 2020
- Primary completion
- Mar 27, 2022
- Completion
- Mar 27, 2022
- Last update posted
- Jun 4, 2023
2020 – 2022
United States locations
- U.S. sites
- 10
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Allergy & Asthma Center | Birmingham | Alabama | 35209 | — |
| Allergy Associates of the Palm Beaches PA | North Palm Beach | Florida | 33408 | — |
| The South Bend Clinic Center for Research | South Bend | Indiana | 56617 | — |
| Institute for Asthma and Allergy | Chevy Chase | Maryland | 20815 | — |
| Washington University | St Louis | Missouri | 63141 | — |
| Optimed Research, LLC | Columbus | Ohio | 43235 | — |
| Allergy, Asthma and Immunology Center, P.C. | Tulsa | Oklahoma | 74136 | — |
| Allergy Partners of North Texas Research | Dallas | Texas | 75230 | — |
| AARA Research Center | Dallas | Texas | 75231 | — |
| Allergy, Asthma & Immunology Clinic, P.A. | Irving | Texas | 75063 | — |
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 NCT04561115, 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 Jun 4, 2023 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04561115 live on ClinicalTrials.gov.