Overview

This trial is active, not recruiting.

Condition hereditary angioedema
Treatment icatibant
Phase phase 3
Sponsor Jerini AG
Start date September 2009
End date January 2011
Trial size 150 participants
Trial identifier NCT00997204, JE049-3101

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Single subcutaneous injection of icatibant, 30 mg
icatibant
Single subcutaneous injection of icatibant, 30 mg

Primary Outcomes

Measure
Clinical safety of self-treatment of acute HAE attacks with s.c. injections of icatibant
time frame: 48 hours post-dose

Secondary Outcomes

Measure
Local tolerability, convenience, and clinical efficacy of self-treatment of acute HAE attacks with s.c. injections of icatibant.
time frame: 48 hours post-dose

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Each patient must meet the following criteria to be enrolled in this study. 1. Males and females 18 years of age at the time of informed consent 2. Documented diagnosis of HAE Type I or II based on ALL of the following criteria: - Family and/or medical history - Characteristic attack manifestations, recurrent attacks - Historical functional C1-INH <50% normal values 3. 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. 4. Mental and physical condition allowing patients to complete baseline assessment, to self-administer icatibant and to follow other study procedures. 5. Ability to provide signed written informed consent after all aspects of the study have been explained and discussed with the patient. Exclusion Criteria: Patients who meet any of the following criteria will be excluded from the study. 1. Participation in a clinical trial of another investigational medicinal product within the past month (except a previous icatibant study). 2. Diagnosis of angioedema other than Type I or Type II HAE. 3. Evidence of symptomatic coronary artery disease based on medical history, in particular, unstable angina pectoris or severe coronary heart disease. 4. Congestive heart failure (NYHA Class 3 and 4). 5. Stroke within the past 6 months. 6. Treatment with angiotensin converting enzyme (ACE) inhibitor. 7. Pregnancy and/or breast-feeding. 8. In the opinion of the investigator: mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study. 9. In the opinion of the investigator: unlikely to comply with the protocol, for example, uncooperative attitude, inability to return for follow-up visits, or unlikely to complete the study for any reason. 10. In the opinion of the investigator: inability to manage study medication or self-administration of an injection.

Additional Information

Official title Open Label, Multicenter Study to Evaluate Safety, Local Tolerability, Convenience, and Efficacy of a Self-Administered Subcutaneous Formulation of Icatibant for the Treatment of Acute Attacks of Hereditary Angioedema
Trial information was received from ClinicalTrials.gov and was last updated in December 2010.
Information provided to ClinicalTrials.gov by Shire Human Genetic Therapies, Inc..