CompletedPhase 3

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

United States, Canada, Jordan147 participantsStarted 2007-04-01

Plain-language summary

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.

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: * 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

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

Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing

Timeframe: 4 hrs post dose after every episode

Trial details

NCT IDNCT00456508

SponsorShire

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-06-01

Results submitted2011-06-29

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