Phase 3
N=96
Efficacy Study of DX-88 (Ecallantide) to Treat Acute Attacks of Hereditary Angioedema (HAE)
Hereditary Angioedema (HAE)
Bottom Line
View on ClinicalTrials.gov: NCT00457015 ↗Enrolled (actual)
96
Serious AEs
3.1%
Results posted
May 2010
Primary outcome: Primary: Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose — 2.2; 2.0; 1.4; 1.6 units on a scale — p=0.010
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ecallantide (Drug); Phosphate Buffer Saline (PBS), pH 7.0 (Drug)
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose |
2.2; 2.0; 1.4; 1.6; -0.8; -0.4 | 0.010 sig |
| SECONDARY Treatment Outcome Score at 4 Hours Post-Dose |
53.4; 8.1 | 0.003 sig |
| SECONDARY Patients With Significant Improvement in Overall Response |
22; 12 | 0.102 |
| SECONDARY Patients With a Successful Response at 4 Hours Post-dosing, Based on the Change From Baseline in the MSCS Score |
45; 28 | — |
| SECONDARY Proportion of Patients Maintaining a Significant Improvement in Overall Response Through 24 Hours |
21; 10 | — |
Summary
The purpose of this study is to evaluate the efficacy and safety of DX-88 (ecallantide) versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema.
Eligibility Criteria
Inclusion Criteria
- 10 years of age or older
- Executed informed consent
- Documented diagnosis of HAE (Type I or II)
- Presentation at the site within 8 hours of patient recognition of an moderate to severe HAE acute attack
Exclusion Criteria
- Receipt of an investigational drug or device, within 30 days prior to study treatment
- Receipt of non-investigational C1-INH within 7 days of treatment
- Receipt of DX-88 (ecallantide) within 3 days prior to study treatment
- Diagnosis of acquired angioedema (AAE), estrogen-dependent angioedema or drug-induced angioedema (including angiotensin-converting enzyme inhibitor induced angioedema)
- Pregnancy or breastfeeding
Data sourced from ClinicalTrials.gov (NCT00457015). 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.