CompletedPhase 3

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

United States91 participantsStarted 2005-12-31

Plain-language 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.

Who can participate

Age range

10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Treatment Outcome Score at 4 Hours Post-Dose

Timeframe: 4 hours post-dose (DOUBLE-BLIND PART)

Trial details

NCT IDNCT00262080

SponsorShire

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-12-31

Results submitted2009-12-30

View on ClinicalTrials.gov More Hereditary Angioedema (HAE) trials

Who can participate

Age range

10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.