CompletedPhase 3

Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE)

Italy85 participantsStarted 2005-03-01

Plain-language summary

Primary Outcome Measures: The primary endpoint was the time to onset of symptom relief of the first attack in the double blind phase. H0: λ icatibant/λ tranexamic acid =1 versus H1: λ icatibant/λ tranexamic acid ≠1 Where: λ icatibant refers to the hazard rate under icatibant and λ tranexamic acid refers to the hazard rate under tranexamic acid. Secondary Outcome Measures: * Additional efficacy assessments (Time to Almost Complete Symptom Relief) * Safety and tolerability * Pharmacoeconomics

Who can participate

Age range

18 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 above 18 years; * Documented diagnosis of HAE Type I or II (confirmed C1-INH deficiency); * Current edema in the cutaneous, abdominal and/or laryngeal areas; * Current edema moderate to severe according to the investigator's Symptom Score. Exclusion Criteria: * Diagnosis of angioedema other than HAE, * Participation in a clinical trial of another investigational medicinal product (IMP)within the past month * Treatment with any pain medication since onset of the current angioedema attack * Treatment with replacement therapy, including C1-INH products, less than 3 days before onset of the current angioedema attack * Treatment with Tranexamic acid replacement therapy within a week before onset of the current angioedema attack * Treatment with ACE inhibitors * Contraindications for Tranexamic acid * Evidence of coronary artery disease based on medical history or Screening examination in particular unstable angina pectoris or severe coronary heart disease * Congestive heart failure (class 3 and 4) * Serum creatinine level of ≥ 250 μmol/L * Serious concomitant illness that the investigator considered to be a contraindication for participation in the trial * Pregnancy (as assessed prior to treatment) and/or breast-feeding

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

Time to Onset of Symptom Relief.

Timeframe: 2 days

Trial details

NCT IDNCT00500656

SponsorShire

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-07-25

Results submitted2013-10-30

View on ClinicalTrials.gov More Hereditary Angioedema trials