Phase 3
N=126
Human C1 Esterase Inhibitor (C1-INH) in Subjects With Acute Abdominal or Facial Hereditary Angioedema (HAE) Attacks
Hereditary Angioedema
Bottom Line
View on ClinicalTrials.gov: NCT00168103 ↗Enrolled (actual)
126
Serious AEs
0.0%
Results posted
Aug 2010
Primary outcome: Primary: Time to Start of Relief of Symptoms From HAE Attack — 1.17; 0.5; 1.5 Hours — p=0.0025
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- C1 Esterase Inhibitor (Biological); Placebo (Biological)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- CSL Behring
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Start of Relief of Symptoms From HAE Attack |
1.17; 0.5; 1.5 | 0.0025 sig |
| SECONDARY Number of Subjects With Worsened Intensity of Clinical HAE Symptoms |
8; 2; 13 | 0.0014 sig |
| SECONDARY Number of Vomiting Episodes |
0; 0; 0 | 0.0329 sig |
Summary
HAE is a rare disorder characterized by functional C1 esterase inhibitor deficiency. If not treated adequately, the acute attacks of HAE can be life-threatening and may even result in fatalities, especially in case of swelling of the larynx. This clinical Phase 2/Phase 3 study was designed to provide clinically relevant data on dosing, efficacy and safety in subjects with HAE.
Eligibility Criteria
Key Inclusion Criteria
- Documented congenital C1-INH deficiency
- Acute facial or abdominal HAE attack
Key Exclusion Criteria
- Acquired angioedema
- Treatment with any other investigational drug within the last 30 days before study entry
- Treatment with any C1-INH concentrate within the previous 7 days
Data sourced from ClinicalTrials.gov (NCT00168103). 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.