Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10%
Public ClinicalTrials.gov record NCT02269163. 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 Study of the Safety, Tolerability, Efficacy, and PK of ProMetic BioTherapeutics IGIV (Human) 10% in Adults and Children With Primary Immunodeficiency Diseases
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Phase 3 multicenter, open-label study of safety, tolerability, efficacy, and pharmacokinetics (PK) of ProMetic's Immune Globulin Intravenous (Human) 10%, the investigational medicinal product \[IMP\]), in Adults and Children with Primary Immunodeficiency Diseases (PIDD).
Study identification
- NCT ID
- NCT02269163
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 82 participants
Conditions and interventions
Conditions
Interventions
- Immune Globulin Intravenous Biological
- Prometic's Immune Globulin Intravenous 10% Biological
Biological
Eligibility (public fields only)
- Age range
- 2 Years to 80 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 26, 2016 (Actual)
- Primary completion
- Jan 11, 2019 (Actual)
- Completion
- Jan 11, 2019 (Actual)
- Last update posted
- Nov 5, 2021
2016 – 2019
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, Irvine | Irvine | California | 92697 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Immunoe International Research | Centennial | Colorado | 80112 | — |
| National Jewish Hospital | Denver | Colorado | 80206 | — |
| Allergy Associates of the Palm Beaches | North Palm Beach | Florida | 33408 | — |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Fort Wayne Medical Institute | Fort Wayne | Indiana | 46815 | — |
| St. Louis University | St Louis | Missouri | 63104 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Optimed Research | Columbus | Ohio | 43236 | — |
| Dallas Allergy Immunology | Dallas | Texas | 75230 | — |
| Bellingham Asthma, Allergy and Immunology Clinic | Bellingham | Washington | 98225 | — |
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 NCT02269163, 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 Nov 5, 2021 · Synced Oct 29, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02269163 live on ClinicalTrials.gov.