Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)
Public ClinicalTrials.gov record NCT00538915. 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
Open Label, Phase III Safety, Efficacy, and Pharmacokinetic Study of NABI-IGIV 10% [Immune Globulin Intravenous (Human), 10%] in Subjects With Primary Immune Deficiency Disorders (PIDD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine if NABI-IGIV (10%) \[Immune Globulin Intravenous (Human), 10%\] is safe and effective in preventing serious bacterial infections (SBIs) in the treatment of patients with primary immune deficiency disorders (PIDD) when compared to historical control data.
Study identification
- NCT ID
- NCT00538915
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 63 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 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
- Sep 2007 (Type not available)
- Primary completion
- Jul 2009 (Actual)
- Completion
- Jul 2009 (Actual)
- Last update posted
- Jul 30, 2021
2007 – 2009
United States locations
- U.S. sites
- 17
- U.S. states
- 15
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | — |
| Precision Trials LLC | Phoenix | Arizona | 85032 | — |
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | — |
| 1st Allergy and Clinical Resaerch center | Centennial | Colorado | 80112 | — |
| Allergy Associates of the Palm Beaches | North Palm Beach | Florida | 33408 | — |
| Marietta Pulmonary Medicine | Marietta | Georgia | 30060 | — |
| Rush University Medical center | Chicago | Illinois | 60612 | — |
| South Bend Clinic LLP | South Bend | Indiana | 46617 | — |
| Kentuky Lung Clinic, PSC | Hazard | Kentucky | 41701 | — |
| Institute For Allergy & Asthma | Wheaton | Maryland | 20902 | — |
| Cardinal Glennon Children's MC | St Louis | Missouri | 63104 | — |
| Women's and Children's Hospital of Buffalo | Buffalo | New York | 14222 | — |
| University Hospital Case medical center | Cleveland | Ohio | 44103 | — |
| Allergy/Immunology Research Center of north Texas | Dallas | Texas | 75230 | — |
| AARA Research | Dallas | Texas | 75231 | — |
| Allergy, Asthma & Immunology Clinic, PA | Irving | Texas | 75063 | — |
| Bellingham Asthma, Allergy 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 NCT00538915, 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 30, 2021 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00538915 live on ClinicalTrials.gov.