CompletedPhase 3

EASSI - Evaluation of the Safety of Self-Administration With Icatibant

Argentina, Austria, Denmark151 participantsStarted 2009-09-25

Plain-language summary

This study is being conducted to explore the clinical safety, local tolerability, convenience and effectiveness of self-treatment of hereditary angioedema (HAE) attacks with subcutaneous injections of icatibant.

Who can participate

Age range18 Years

SexALL

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

Inclusion criteria

✓. Males and females 18 years of age at the time of informed consent
✓. Documented diagnosis of HAE Type I or II based on ALL of the following criteria:
✓. Women of childbearing potential must use consistently and correctly a highly effective, adequate method of birth control (failure rate less than 1% per year) - sexual abstinence or have a vasectomised partner during the duration of the study. Hormonal contraception can be continued if verified by a physician that it doesn't affect the course of HAE attacks.
✓. Mental and physical condition allowing patients to complete baseline assessment, to self-administer icatibant and to follow other study procedures.
✓. Ability to provide signed written informed consent after all aspects of the study have been explained and discussed with the patient.

Exclusion criteria

✕. Participation in a clinical trial of another investigational medicinal product within the past month (except a previous icatibant study).
✕. Diagnosis of angioedema other than Type I or Type II HAE.
✕. Evidence of symptomatic coronary artery disease based on medical history, in particular, unstable angina pectoris or severe coronary heart disease.
✕. Congestive heart failure (NYHA Class 3 and 4).
✕. Stroke within the past 6 months.
✕. Treatment with angiotensin converting enzyme (ACE) inhibitor.
✕. Pregnancy and/or breast-feeding.
✕. In the opinion of the investigator: mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study.

What they're measuring

Number of Participants With Adverse Events in Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant

Timeframe: 7 days from the beginning of each phase

Trial details

NCT IDNCT00997204

SponsorShire

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-06-22

Results submitted2013-11-04

View on ClinicalTrials.gov More Hereditary Angioedema trials