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

Shire

Status and phase: Completed; Phase 3

Conditions: Hereditary Angioedema (HAE)

Treatments: Drug: ecallantide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00456508

DX-88/19

Details and patient eligibility

About

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.

Full description

This is an open label trial.

The study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide in the treatment of acute attacks of hereditary angioedema. This study is designed to provide efficacy and safety data on repeated use of 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: 147 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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147 participants in 1 patient group

DX-88 (ecallantide)

Experimental group

Description:

DX-88 (ecallantide) Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose.

Treatment:

Drug: ecallantide