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NCT01005888 · ClinicalTrials.gov registry record · Phase 3
C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 26
- Enrollment target
NCT01005888: Completed Phase 3 study, sponsored by Shire.
NCT01005888 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 26 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01005888, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 26 participants
- Enrollment target
Study Summary
The study objective was to determine the safety and efficacy of C1INH-nf for the prevention of acute HAE attacks.
Primary Outcome
An HAE attack was defined as the subject-reported indication of swelling at any location following a report of no swelling on the previous day. Analyses include observed attack counts and normalized attack counts (i.e., the number of attacks observed during each therapy period, normalized for the number of days the subject participated in that period).
Interventions
- DRUG Placebo (saline)
- BIOLOGICAL C1 esterase inhibitor [human] (C1INH-nf)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2005-03-14 |
| Est. Completion | 2007-08-22 |
| Phase | Phase 3 |
What the finished NCT01005888 record still lists
NCT01005888 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo (saline) is the first listed.
NCT01005888 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01005888 about?
NCT01005888 is a clinical study titled "C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks". The study objective was to determine the safety and efficacy of C1INH-nf for the prevention of acute HAE attacks.
What is the current status of trial NCT01005888?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 26 participants. The study started on 2005-03-14. Estimated completion is 2007-08-22.
What interventions are being tested in trial NCT01005888?
The interventions under investigation include: Placebo (saline) (DRUG), C1 esterase inhibitor [human] (C1INH-nf) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01005888?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01005888's enrollment target sits among peer trials
26 1937th of 2000 higher than 60 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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