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

Shire

Status and phase: Completed; Phase 3

Conditions: Hereditary Angioedema (HAE)

Treatments: Drug: Phosphate Buffer Saline (PBS), pH 7.0; Drug: ecallantide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00457015

EDEMA4 (DX-88/20)

Details and patient eligibility

About

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.

Full description

This is a randomized placebo-controlled trial.

The study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema. This study is conducted under Special Protocol Assessment with the FDA and is designed to provide pivotal efficacy data on ecallantide. These data are intended to support the marketing authorization of ecallantide in the treatment of acute attacks of hereditary angioedema. Efficacy and safety of ecallantide will be evaluated in this study.

Enrollment: 96 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 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:

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

Treatment:

Drug: Phosphate Buffer Saline (PBS), pH 7.0