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COMPLETED Phase 3

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

NCT00289211 · View on ClinicalTrials.gov ↗

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

56 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00289211

The ClinicalTrials.gov registry entry for NCT00289211 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 56 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00289211 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00289211?

The interventions under investigation include: Placebo (saline) (DRUG), C1 esterase inhibitor [human] (C1INH-nf) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00289211?

This trial is sponsored by Shire, which has 56 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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