Phase 3 N=72 Randomized Quadruple-blind Treatment

Efficacy and Safety Study of DX-88 to Treat Acute Attacks of Hereditary Angioedema (HAE)

Hereditary Angioedema (HAE)

Bottom Line

View on ClinicalTrials.gov: NCT00262080 ↗

Enrolled (actual)

Serious AEs

8.6%

Results posted

May 2010

Primary outcome: Primary: Treatment Outcome Score at 4 Hours Post-Dose — 49.5; 18.5 units on a scale — p=0.037

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: ecallantide (Drug); Phosphate Buffer Saline (PBS), (Drug)
Age: Pediatric, Adult, Older Adult · 10+ yrs
Sex: All
Sponsor: Shire
Primary completion: Dec 2005

Outcome Measures

Outcome	Result	p-value
PRIMARY Treatment Outcome Score at 4 Hours Post-Dose	49.5; 18.5	0.037 sig
SECONDARY Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose	2.17; 2.24; 1.26; 1.75; -0.91; -0.48	0.044 sig
SECONDARY Time to Significant Improvement in Overall Response	19; 11; 17; 25	0.055

Summary

The purpose of this study is to determine if a subcutaneous dose of DX-88 (ecallantide; an investigational product) is safe and relieves symptoms of HAE in patients suffering from moderate to severe acute attacks of HAE.

Eligibility Criteria

Inclusion Criteria

Age 10 and older
Documented diagnosis of HAE, Type I or II
Executed informed consent
Presentation for treatment within 8 hours of patient recognition of moderate to severe HAE attack

Exclusion Criteria

Receipt of investigational drug or device, other than DX-88, within 30 days of treatment
Receipt of non-investigational C1-INH (C1 esterase inhibitor) within 7 days of treatment
Diagnostic of acquired angioedema, estrogen-dependent angioedema or drug induced angioedema
Pregnancy or breastfeeding
Patients who have received DX-88 within 7 days of presentation for dosing in the Double-blind Phase

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00262080). 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.