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

Shire

Status and phase: Completed; Phase 3

Conditions: Hereditary Angioedema (HAE)

Treatments: Drug: ecallantide; Drug: Phosphate Buffer Saline (PBS),

Study type: Interventional

Funder types: Industry

Identifiers

NCT00262080

EDEMA3 (DX-88/14)

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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91 participants in 2 patient groups, including a placebo group

DX-88 (ecallantide)

Experimental group

Description:

DX-88 (ecallantide) 30 mg given as three 10 mg/mL subcutaneous injections.

Treatment:

Drug: ecallantide

Placebo

Placebo Comparator group

Description:

Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.

Treatment:

Drug: Phosphate Buffer Saline (PBS),