Clinical trial
Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute…
NCT00438815 · Shire, Industry · Completed
Key facts
| NCT number | NCT00438815 |
|---|---|
| Title | Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks |
| Official title | LEVP2006-1 CHANGE 2 Trial (C1-Inhibitor in Hereditary Angioedema Nanofiltration Generation Evaluating Efficacy): Open-Label Safety/Efficacy Repeat Exposure Study of C1INH-nf (Human) in the Treatment of Acute HAE Attacks |
| Acronym | CHANGE 2 |
| Lead sponsor | Shire, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Hereditary Angioedema |
| Intervention type | Biological |
| Interventions | C1 esterase inhibitor [human] (C1INH-nf) |
| Enrollment | 113 |
| Start date | Sep 21, 2006 |
| Primary completion | Mar 31, 2009 |
| Completion | Mar 31, 2009 |
| First posted | Feb 22, 2007 |
| Last update posted | Jun 8, 2021 |
| Countries | United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: