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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hereditary Angioedema (HAE)

In brief

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.

Key facts

Study ID

NCT00262080

Run by

Shire

People needed

91

Starts

2005-12-31

Expected to finish

2007-02-28

Last updated by the study team

2021-06-11

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Institute for Asthma and Allergy — Wheaton, Maryland, United States

Full record on ClinicalTrials.gov

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