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Completed Phase 3 Interventional Results available

Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks

ClinicalTrials.gov ID: NCT00462709

Public ClinicalTrials.gov record NCT00462709. 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 22, 2026, 10:51 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

LEVP2006-4 CHANGE 3 Trial (C1-Inhibitor in Hereditary Angioedema Nanofiltration Generation Evaluating Efficacy): Open-Label Use of C1INH-nf (Human) for the Prophylactic Treatment to Prevent HAE Attacks and as Treatment in Acute HAE Attacks

Brief summary

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

The study objective was to evaluate the safety and efficacy of prophylactic use of C1INH-nf for the prevention of acute HAE attacks.

Study identification

NCT ID
NCT00462709
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Shire
Industry
Enrollment
146 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
1 Year 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 27, 2006 (Actual)
Primary completion
Mar 31, 2009 (Actual)
Completion
Mar 31, 2009 (Actual)
Last update posted
Jun 8, 2021

2006 – 2009

United States locations

U.S. sites
48
U.S. states
29
U.S. cities
48
Facility City State ZIP Site status
Clinical Research Consultants, Inc Hoover Alabama 35216 —
Allergy and Immunology Associates Scottsdale Arizona 85251 —
Allergy and Asthma Clinic of Northwest Arkansas Bentonville Arkansas 72712 —
UCLA-David Geffen School of Medicine Los Angeles California 90095 —
University of California, San Diego San Diego California 92093 —
Allergy and Asthma Associates of Santa Clara San Jose California 95117 —
Allergy and Asthma Clinical Research, Inc Walnut Creek California 94598 —
Allergy and Asthma Center Fort Lauderdale Florida 33334 —
Allergy and Asthma Center of East Orlando Orlando Florida 32826 —
Cleveland Clinic Weston Florida 33331 —
Family Allergy and Asthma Center Atlanta Georgia 30342 —
Atlanta Allergy and Asthma Clinic Suwanee Georgia 30024 —
University Consultants in Allergy & Immunology Chicago Illinois 60612 —
Welborn Clinic Evansville Indiana 47713 —
Private Practice Liberal Kansas 67901 —
Olathe Medical Center Olathe Kansas 66061 —
Graves-Gilbert Clinic Bowling Green Kentucky 42101 —
Family Asthma and Allergy Research Center Louisville Kentucky 40215 —
Asthma Allergy and Sinus Center Waldorf Maryland 20602 —
Institute for Asthma and Allergy Wheaton Maryland 20902 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Grand Traverse Allergy Traverse City Michigan 49684 —
MeritCare Clinical Research Bemidji Minnesota 56601 —
University of Mississippi Medical Center Jackson Mississippi 39216 —
St. Louis University School of Medicine St Louis Missouri 63110 —
Nevada Access to Research and Education Society Las Vegas Nevada 89102 —
UMDNJ Asthma and Allergy Research Center Newark New Jersey 07103 —
Private Practice Hastings-on-Hudson New York 10706 —
Winthrop University Hospital Mineola New York 11501 —
Mount Sinai School of Medicine New York New York 10029 —
Montefiore Medical Center The Bronx New York 10461 —
Allergy Partners of East Carolina Greenville North Carolina 27858 —
Legacy Pharma Research Bismarck North Dakota 58501 —
MeritCare Clinical Research Fargo North Dakota 58122 —
Nationwide Childrens Hospital Clinical Research Columbus Ohio 43205 —
Allergy Clinic of Tulsa Tulsa Oklahoma 74133 —
Oregon Medical Group Eugene Oregon 97401 —
Allergy Asthma and Dermatology Research Center Lake Oswego Oregon 97035 —
Penn State University Hershey Pennsylvania 17033 —
AARA Research Center Dallas Texas 75231 —
University of Texas Medical Branch Galveston Texas 77555-1083 —
University of Texas - Pediatric Pulmonary/Allergy and Immunology Houston Texas 77030 —
Allergy and Asthma Research Center San Antonio Texas 78229 —
Tyler County Hospital Woodville Texas 75979 —
Virginia Adult and Pediatric Allergy and Asthma Richmond Virginia 23229 —
Marycliff Allergy Specialists Spokane Washington 99204 —
Puget Sound Allergy, Asthma and Immunology Tacoma Washington 98405 —
St. Joseph's Hospital/Cornerstone Healthcare Parkersburg West Virginia 26102 —

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 NCT00462709, 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 Jun 8, 2021 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00462709 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →