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Completed Phase 3 Interventional Results available

Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)

ClinicalTrials.gov ID: NCT01581593

Public ClinicalTrials.gov record NCT01581593. 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 21, 2026, 10:20 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Multicenter, Open-label, Historically Controlled, Phase III Study to Assess the Efficacy, Tolerability, Safety and Pharmacokinetics of Kedrion IVIG 10% in Adult and Pediatric Subjects With Primary Immunodeficiency (PID).

Study identification

NCT ID
NCT01581593
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Kedrion S.p.A.
Industry
Enrollment
45 participants

Conditions and interventions

Interventions

  • Kedrion IVIG 10% Biological

Biological

Eligibility (public fields only)

Age range
2 Years to 70 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
Nov 11, 2012
Primary completion
Aug 26, 2014
Completion
Aug 26, 2014
Last update posted
Feb 15, 2021

2012 – 2014

United States locations

U.S. sites
12
U.S. states
11
U.S. cities
11
Facility City State ZIP Site status
Arkansas Children's Hospital Little Rock Arkansas 72202
Allergy Associates of the Palm Beaches North Palm Beach Florida 33408
Family Allergy & Asthma Center, PC Atlanta Georgia 30342
Rush University Chicago Illinois 60612
University of Iowa Hospital and Clinics Iowa City Iowa 52242
Midwest Immunology Clinic Plymouth Minnesota 55446
AAIR Research Center Rochester New York 14618
Optimed Research, LTD Columbus Ohio 43235
Dallas Allergy Immunology Research Dallas Texas 75230
AARA Research Center Dallas Texas 75231
Virginia Commonwealth University Health Systems Richmond Virginia 23298
Marycliff Allergy Specialists Spokane Washington 99204

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 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01581593, 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 Feb 15, 2021 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01581593 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →