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Completed Phase 3 Interventional

Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders

ClinicalTrials.gov ID: NCT00157079

Public ClinicalTrials.gov record NCT00157079. 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 Oct 21, 2026, 6:34 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 Investigation to Assess the Safety and Efficacy of Immune Globulin Intravenous (Human), 10% in Subjects With Primary Immunodeficiency Disorders

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to assess the safety and efficacy of Immune Globulin Intravenous (Human), 10% (IGIV 10%) in subjects with primary immunodeficiency disorders.

Study identification

NCT ID
NCT00157079
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Baxalta now part of Shire
Industry
Enrollment
61 participants

Conditions and interventions

Eligibility (public fields only)

Age range
24 Months 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
Jun 25, 2002 (Actual)
Primary completion
Dec 16, 2003 (Actual)
Completion
Dec 16, 2003 (Actual)
Last update posted
Aug 24, 2021

2002 – 2003

United States locations

U.S. sites
11
U.S. states
8
U.S. cities
11
Facility City State ZIP Site status
Children´s Hospital Los Angeles Los Angeles California 90027 —
Stanford University Medical Center Stanford California 94304-8786 —
1st Allergy and Clinical Research Center Englewood Colorado 80112 —
Allergy Associates of the Palm Beaches North Palm Beach Florida 33408 —
University of South Florida; Asthma, Allergy & Immunology CRU Tampa Florida 33613 —
Rush Presbyterian - St. Lukes Medical Center Chicago Illinois 60612 —
Children´s Hospital Boston Boston Massachusetts 02115 —
Allergy, Asthma & Immunology Assoc. Omaha Nebraska 68124 —
Asthma and Allergy Center Papillion Nebraska 68046 —
Montefiore Medical Center, Albert Einstein College of Medicine The Bronx New York 10461 —
Pediatric Allergy/Immunology Associates Dallas Texas 75230 —

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 NCT00157079, 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 Aug 24, 2021 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00157079 live on ClinicalTrials.gov.

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