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NCT00462709 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Hereditary Angioedema, sponsored by Shire.

Completed
Registry status
Phase 3
Development phase
146
Enrollment target
20
Study locations

NCT00462709 is a Phase 3 study of Hereditary Angioedema that has completed, run by Shire. The registered enrollment target is 146 participants, above the 65-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (125% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT00462709, a Phase 3 study of Hereditary Angioedema, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 3
Development phase
146 participants
Enrollment target
20
Study locations

Study Summary

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

Conditions Studied

Interventions

  • BIOLOGICAL C1 esterase inhibitor [human] (C1INH-nf)

Study Locations (20)

California

  • UCLA-David Geffen School of Medicine - Los Angeles
  • University of California, San Diego - San Diego
  • Allergy and Asthma Associates of Santa Clara - San Jose
  • Allergy and Asthma Clinical Research, Inc - Walnut Creek

Florida

  • Allergy and Asthma Center - Fort Lauderdale
  • Allergy and Asthma Center of East Orlando - Orlando
  • Cleveland Clinic - Weston

Georgia

  • Family Allergy and Asthma Center - Atlanta
  • Atlanta Allergy and Asthma Clinic - Suwanee

Kansas

  • Private Practice - Liberal
  • Olathe Medical Center - Olathe

Kentucky

  • Graves-Gilbert Clinic - Bowling Green
  • Family Asthma and Allergy Research Center - Louisville

Maryland

  • Asthma Allergy and Sinus Center - Waldorf
  • Institute for Asthma and Allergy - Wheaton

Alabama

  • Clinical Research Consultants, Inc - Hoover

Arizona

  • Allergy and Immunology Associates - Scottsdale

Trial Details

FieldValue
Enrollment Target 146 participants
Start Date 2006-06-27
Est. Completion 2009-03-31
Phase Phase 3

Sponsor

Shire

245 total trials

What the Registry Record Tells You About NCT00462709

The ClinicalTrials.gov registry entry for NCT00462709 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 146 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 65-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (125% higher). The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hereditary Angioedema appearing as the primary indexed condition, and to 1 intervention - of which C1 esterase inhibitor [human] (C1INH-nf) is the first listed.

NCT00462709 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT00462709 about?

NCT00462709 is a clinical study titled "Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks". The study objective was to evaluate the safety and efficacy of prophylactic use of C1INH-nf for the prevention of acute HAE attacks.

What is the current status of trial NCT00462709?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 146 participants. The study started on 2006-06-27. Estimated completion is 2009-03-31.

What conditions does trial NCT00462709 study?

This clinical trial studies the following conditions: Hereditary Angioedema.

What interventions are being tested in trial NCT00462709?

The interventions under investigation include: C1 esterase inhibitor [human] (C1INH-nf) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00462709?

This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00462709 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.