Phase 3
Completed N=57
C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study)
Source: ClinicalTrials.gov NCT00292981 ↗Enrolled (actual)
57
Serious AEs
1.8%
Results posted
Jun 2011
Primary outcomePrimary: Time to Start of Relief of Symptoms From HAE Attack (Intent to Treat (ITT) Subject Population) — 0.46 hours
Summary
Hereditary angioedema (HAE) is a rare disorder characterized by congenital lack of functional C1 esterase inhibitor. If not treated adequately, the acute attacks of HAE can be life-threatening and may even result in fatalities, especially in case of involvement of the larynx.The planned extension study is designed to enrol subjects that participated in the pivotal study in order to provide them with C1-INH for treatment of acute HAE attacks for 24 months or until the licensing procedure for C1-INH is finalized, whatever comes first.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Start of Relief of Symptoms From HAE Attack (Intent to Treat (ITT) Subject Population) |
0.46 | — |
| PRIMARY Time to Start of Relief of Symptoms From HAE Attack (ITT Attack Population) |
0.37 | — |
| SECONDARY Time to Complete Resolution of All HAE Symptoms (ITT Subject Population) |
15.48 | — |
| SECONDARY Time to Complete Resolution of All HAE Symptoms (ITT Attack Population) |
14.28 | — |
Eligibility Criteria
Key Inclusion Criteria
- Documented congenital C1-INH deficiency
- Acute HAE attack
- Participation in base study CE1145\_3001 (NCT00168103)
Key Exclusion Criteria
- Acquired angioedema
- Treatment with any other investigational drug besides CE1145 in the last 30 days before study entry
Data sourced from ClinicalTrials.gov (NCT00292981). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.