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NCT01457430 · ClinicalTrials.gov registry record · Phase 4
Efficacy, Safety and Tolerability of Icatibant for the Treatment of HAE
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 19
- Enrollment target
NCT01457430: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT01457430 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 19 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01457430, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 19 participants
- Enrollment target
Study Summary
The investigators propose a study to evaluate the safety, local tolerability, convenience, and efficacy of self-administered Icatibant for the treatment of acute attacks of hereditary angioedema. The investigators believe that self administration with Icatibant for treatment of an acute attack of angioedema will not change the time to complete or near complete resolution of symptoms compared to treatment with Icatibant in a medical facility.
Primary Outcome
Time of onset of HAE attack, time icatibant was administered, and time to complete relief of symptoms were recorded in minutes. Time to complete relief of symptoms was defined as time from onset of symptoms to complete or near complete resolution as reported by the patient.
Interventions
- DRUG Icatibant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-04 |
| Phase | Phase 4 |
What the finished NCT01457430 record still lists
NCT01457430 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Icatibant is the first listed.
NCT01457430 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01457430 about?
NCT01457430 is a clinical study titled "Efficacy, Safety and Tolerability of Icatibant for the Treatment of HAE". The investigators propose a study to evaluate the safety, local tolerability, convenience, and efficacy of self-administered Icatibant for the treatment of acute attacks of hereditary angioedema. The investigators believe that self administration with Icatibant for treatment of an acute attack of an...
What is the current status of trial NCT01457430?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 19 participants. The study started on 2011-12. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01457430?
The interventions under investigation include: Icatibant (DRUG).
Who is sponsoring clinical trial NCT01457430?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01457430's enrollment target sits among peer trials
19 1834th of 2000 higher than 159 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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