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NCT00289211 · ClinicalTrials.gov registry record · Phase 3

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

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

Completed
Registry status
Phase 3
Development phase
83
Enrollment target
20
Study locations

NCT00289211 is a Phase 3 study of Hereditary Angioedema that has completed, run by Shire. The registered enrollment target is 83 participants, above the 70-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (19% higher). The trial reports 20 study locations across 15 states.

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The verdict

NCT00289211, a Phase 3 study of Hereditary Angioedema, has completed, sponsored by Shire.

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

Study Summary

The study objective was to determine the safety and efficacy of C1INH-nf for the treatment of acute HAE attacks.

Conditions Studied

Interventions

  • DRUG Placebo (saline)
  • 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 Clinical Research, Inc - Walnut Creek

Florida

  • Allergy and Asthma Center - Fort Lauderdale
  • Orlando Regional Healthcare - Orlando

Massachusetts

  • Allergy Asthma and Immunology - Falmouth
  • University of Massachusetts Medical School - Worcester

New York

  • Winthrop University Hospital - Mineola
  • Mount Sinai School of Medicine - New York

Alabama

  • Clinical Research Consultants, Inc - Hoover

Arizona

  • Allergy and Immunology Associates - Scottsdale

Georgia

  • Family Allergy and Asthma Center - Atlanta

Indiana

  • Welborn Clinic Allergy and Immunology - Evansville

Trial Details

FieldValue
Enrollment Target 83 participants
Start Date 2005-03-14
Est. Completion 2007-04-13
Phase Phase 3

Sponsor

Shire

245 total trials

What the Registry Record Tells You About NCT00289211

The ClinicalTrials.gov registry entry for NCT00289211 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 70-participant average among 14 other Hereditary Angioedema trials with a reported enrollment target (19% 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 2 interventions - of which Placebo (saline) is the first listed.

NCT00289211 reports 20 study locations spanning 15 distinct geographic areas - top geographies include California, Florida, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT00289211 about?

NCT00289211 is a clinical study titled "C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks". The study objective was to determine the safety and efficacy of C1INH-nf for the treatment of acute HAE attacks.

What is the current status of trial NCT00289211?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 83 participants. The study started on 2005-03-14. Estimated completion is 2007-04-13.

What conditions does trial NCT00289211 study?

This clinical trial studies the following conditions: Hereditary Angioedema.

What interventions are being tested in trial NCT00289211?

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

Who is sponsoring clinical trial NCT00289211?

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

Where is trial NCT00289211 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. 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

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