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Completed Phase 3 Interventional Results available

Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks

ClinicalTrials.gov ID: NCT01188564

Public ClinicalTrials.gov record NCT01188564. 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 22, 2026, 6:50 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 Phase III Randomized, Double-blind, Placebo-controlled Study With an Open-label Extension Evaluating the Efficacy, Safety and Immunogenicity of Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks of Angioedema in Patients With HAE

Study identification

NCT ID
NCT01188564
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Pharming Technologies B.V.
Industry
Enrollment
75 participants

Conditions and interventions

Interventions

  • rhC1INH Drug
  • Placebo (Saline) Drug

Drug

Eligibility (public fields only)

Age range
13 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
Dec 31, 2010
Primary completion
Nov 30, 2012
Completion
Feb 28, 2013
Last update posted
Aug 6, 2015

2011 – 2013

United States locations

U.S. sites
15
U.S. states
11
U.S. cities
15
Facility City State ZIP Site status
Allergy, Asthma & Immunology, Assoc, Ltd. Scottsdale Arizona 85251
Allergy and Asthma Institute of the Valley Granada Hills California 91344
UCLA Department of Medicine Division of Clinical Immunology, David Geffen School of Medicine Los Angeles California 90095
USF Asthma, Allergy and Immunology Clinical Research Unit Tampa Florida 33613
Family Allergy and Asthma Center Atlanta Georgia 30342
Institute for Asthma and Allergy, P.C. Chevy Chase Maryland 20815
Asthma & Allergy Center - Washington University School of Medicine St Louis Missouri 63141
University of Cincinnati Physicians, Inc. Cincinnati Ohio 45267
Optimed Research, LTD Columbus Ohio 43235
Baker Allergy, Asthma and Dermatology Research Center, LLC Lake Oswego Oregon 97035
Pennsylvania State- Milton S. Hershey Medical Center Hershey Pennsylvania 17033
AARA Research Center Dallas Texas 75231
University of Texas - Medical Branch Galveston Texas 77555
Allergy, Asthma & Immunology Clinic, P.A. Irving Texas 75063
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 12 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01188564, 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 6, 2015 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01188564 live on ClinicalTrials.gov.

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