Phase 3
Completed N=147
Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE)
Hereditary Angioedema (HAE)
Source: ClinicalTrials.gov NCT00456508 ↗
Enrolled (actual)
147
Serious AEs
18.4%
Results posted
Dec 2012
Primary outcomePrimary: Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing — -1.04; -1.06; -1.07; -1.15 scores on a scale
Summary
The purpose of this study is to evaluate the efficacy and safety of repeated doses of ecallantide in the treatment of acute attacks of hereditary angioedema and to allow HAE patients continued access to ecallantide. In addition, patients enrolled in DX-88/20 (EDEMA4) trial will be followed up and treated for subsequent attacks in this trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing |
-1.04; -1.06; -1.07; -1.15; -1.16; -1.07 | — |
| SECONDARY Treatment Outcome Score (TOS) at 4 Hrs Post Dosing, Based on the Patient Assessment of Baseline Severity of Symptoms |
69.80; 70.05; 63.08; 62.65; 65.13; 60.42 | — |
| SECONDARY Time to Significant Improvement |
225.2; 194.5; 225.4; 198.1; 240.0; 225.2 | — |
Eligibility Criteria
Inclusion Criteria
- 10 years of age or older
- Documented diagnosis of HAE (Type I or II)
- Willing and able to give informed consent
- Acute HAE attack at time of presentation
Exclusion Criteria
- Receipt of an investigational drug or device, within 30 days prior to study treatment, other than DX-88 (ecallantide)
- Pregnancy or breastfeeding
- Receipt of non-investigational C1-INH or DX-88 within 72 hours of treatment
- Patients eligible for current, ongoing clinical trial in which DX 88 (ecallantide) is offered
Data sourced from ClinicalTrials.gov (NCT00456508). 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.