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Completed Phase 3 Interventional Results available

Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10%

ClinicalTrials.gov ID: NCT02269163

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.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 5:05 AM EDT

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

Study identification

NCT ID
NCT02269163
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Prometic Biotherapeutics, Inc.
Industry
Enrollment
82 participants

Conditions and interventions

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 25, 2016
Primary completion
Jan 10, 2019
Completion
Jan 10, 2019
Last update posted
Nov 4, 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 4, 2021 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02269163 live on ClinicalTrials.gov.

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