Status:
COMPLETED
Efficacy, Safety and Tolerability of Icatibant for the Treatment of HAE
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Shire Human Genetic Therapies, Inc.
Conditions:
Hereditary Angioedema
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The investigators propose a study to evaluate the safety, local tolerability, convenience, and efficacy of self-administered Icatibant for the treatment of acute attacks of hereditary angioedema. The ...
Eligibility Criteria
Inclusion
- Males and females at least 18 years of age at the time of informed consent
- Documented diagnosis of hereditary angioedema Type I or II based on ALL of the following criteria:
- Family and/or medical history
- Characteristic attack manifestations, recurrent attacks
- Historical low C4, normal C1q and either low C1-INH or low C1INH function
- 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 hereditary angioedema 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
- Participation in a clinical therapeutic 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 hereditary angioedema.
- 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 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.
- 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.
- In the opinion of the investigator: inability to complete the patient diary, manage study medication or self-administration of an injection.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01457430
Start Date
December 1 2011
End Date
April 1 2014
Last Update
October 18 2016
Active Locations (5)
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1
San Diego Veterans Affairs Medical Center
La Jolla, California, United States
2
UCLA - David Geffen School of Medicine
Los Angeles, California, United States
3
Institute for Allergy and Asthma
Wheaton, Maryland, United States, 20902
4
Penn State University
Hershey, Pennsylvania, United States, 17033