Phase 2/3 Study of IGSC, 20% in PIDD

ClinicalTrials.gov ID: NCT01218438

Public ClinicalTrials.gov record NCT01218438. 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 22, 2026, 3:13 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 Clinical Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) for the Evaluation of Efficacy, Safety, Tolerability and Pharmacokinetics in Subjects With Primary Immunodeficiency Diseases (PIDD)

Study identification

NCT ID: NCT01218438
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2, Phase 3
Lead sponsor: Baxalta now part of Shire; Industry
Enrollment: 86 participants

Conditions and interventions

Conditions

Primary Immunodeficiency Diseases (PID)

Interventions

Immune Globulin Intravenous (Human), 10% Solution Biological
Immune Globulin Subcutaneous (Human), 20% Solution Drug

Biological · Drug

Eligibility (public fields only)

Age range: 2 Years and older
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 27, 2013
Primary completion: Mar 12, 2015
Completion: Mar 12, 2015
Last update posted: Jul 19, 2021

2013 – 2015

United States locations

U.S. sites: 16
U.S. states: 14
U.S. cities: 16

Facility	City	State	ZIP	Site status
University of California, Irvine	Irvine	California	92697	—
IMMUNOe International Research Centers	Centennial	Colorado	80112	—
Allergy Associates of the Palm Beaches	North Palm Beach	Florida	33408	—
Emory University	Atlanta	Georgia	30322	—
Rush University Medical Center	Chicago	Illinois	60612	—
Family Allergy and Asthma Research Institute	Louisville	Kentucky	40215	—
Children's Hospital New Orleans- LSUHSC School of Medicine	New Orleans	Louisiana	70118	—
Midwest Immunology Clinical and Infusion Center	Plymouth	Minnesota	55446	—
SSM Cardinal Glennon Children's Medical Center	St Louis	Missouri	63104	—
Montefiore Medical Center Division of Allergy/Immunology	The Bronx	New York	10461	—
Oklahoma Institute of Allergy and Asthma Clinical Research	Oklahoma City	Oklahoma	73131	—
Vital Prospects Clinical Research Institute, PC	Tulsa	Oklahoma	74136	—
Dallas Allergy Immunology Research	Dallas	Texas	75230	—
Allergy Asthma and Immunology Clinic PA	Irving	Texas	75063	—
Rocky Mountain Asthma/Allergy/Immunology	Layton	Utah	84041	—
Medical College of Wisconsin	Milwaukee	Wisconsin	53226	—

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 2 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01218438, 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 Jul 19, 2021 · Synced Jul 22, 2026

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The complete protocol, eligibility criteria, and contact information for NCT01218438 live on ClinicalTrials.gov.

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