Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency

ClinicalTrials.gov ID: NCT02604810

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.

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ClinicalTrials.gov public records Last synced Jul 21, 2026, 4:39 PM EDT

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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

Study identification

NCT ID: NCT02604810
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Grifols Therapeutics LLC; Industry
Enrollment: 53 participants

Conditions and interventions

Conditions

Primary Immunodeficiency

Interventions

IGIV-C 10% Biological
IGSC 20% Biological

Biological

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: Dec 31, 2015
Primary completion: Aug 31, 2017
Completion: Nov 30, 2017
Last update posted: Oct 3, 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 3, 2019 · Synced Jul 21, 2026

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The complete protocol, eligibility criteria, and contact information for NCT02604810 live on ClinicalTrials.gov.

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