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NCT00438815 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Shire.

Completed
Registry status
Phase 3
Development phase
113
Enrollment target

NCT00438815: Completed Phase 3 study, sponsored by Shire.

NCT00438815 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 113 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00438815, a Phase 3 study, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 3
Development phase
113 participants
Enrollment target

Study Summary

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

Interventions

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

Trial Details

FieldValue
Enrollment Target 113 participants
Start Date 2006-09-21
Est. Completion 2009-03-31
Phase Phase 3
Shire

245 total trials

What the finished NCT00438815 record still lists

NCT00438815 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).

The record links to 0 conditions, and to 1 intervention - of which C1 esterase inhibitor [human] (C1INH-nf) is the first listed.

NCT00438815 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00438815 about?

NCT00438815 is a clinical study titled "Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks". The study objective was to evaluate the safety and efficacy of repeat use of C1INH-nf for the treatment of acute HAE attacks.

What is the current status of trial NCT00438815?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 113 participants. The study started on 2006-09-21. Estimated completion is 2009-03-31.

What interventions are being tested in trial NCT00438815?

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

Who is sponsoring clinical trial NCT00438815?

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

How this trial's enrollment target compares

Where NCT00438815's enrollment target sits among peer trials

113 1651st of 2000 higher than 349 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00438815, the US trial registry maintained by the National Library of Medicine. NCT00438815 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.