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NCT02586805 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 125
- Enrollment target
NCT02586805: Completed Phase 3 study, sponsored by Shire.
NCT02586805 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 125 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02586805, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 125 participants
- Enrollment target
Study Summary
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of DX-2930 in preventing acute angioedema attacks in patients with Type I and Type II HAE.
Primary Outcome
HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Rate of investigator confirmed HAE attacks was analyzed using a generalized linear model (GLM) for count data assuming a poisson distribution with a log link function and Pearson chi-square scaling of standard errors to account for potential overdispersion. The logarithm of time in days each subject was observed during the treatment period was used as an offset varia
Interventions
- DRUG Placebo
- DRUG DX-2930 - 300mg/2wk
- DRUG DX-2930 - 300mg/4wk
- DRUG DX-2930 - 150mg/4wk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2016-03-03 |
| Est. Completion | 2017-04-13 |
| Phase | Phase 3 |
What the finished NCT02586805 record still lists
NCT02586805 is an interventional study that assigns participants to a tested intervention. The registered 125 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 (84% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02586805 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02586805 about?
NCT02586805 is a clinical study titled "Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE". This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of DX-2930 in preventing acute angioedema attacks in patients with Type I and Type II HAE.
What is the current status of trial NCT02586805?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 125 participants. The study started on 2016-03-03. Estimated completion is 2017-04-13.
What interventions are being tested in trial NCT02586805?
The interventions under investigation include: Placebo (DRUG), DX-2930 - 300mg/2wk (DRUG), DX-2930 - 300mg/4wk (DRUG), DX-2930 - 150mg/4wk (DRUG).
Who is sponsoring clinical trial NCT02586805?
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 NCT02586805's enrollment target sits among peer trials
125 1605th of 2000 higher than 391 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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