Efficacy, Safety and Tolerability of a Self-Administered Subcutaneous Formulation of Icatibant for the Treatment of Acute Attacks of Hereditary Angioedema (IHA)
This study has been completed.
Shire Human Genetic Therapies, Inc.
Information provided by (Responsible Party):
Aleena Banerji, Massachusetts General Hospital
First received: October 13, 2011
Last updated: July 21, 2014
Last verified: July 2014
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 investigators believe that self administration with Icatibant for treatment of an acute attack of angioedema will not change the time to complete or near complete resolution of symptoms compared to treatment with Icatibant in a medical facility.
||Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
||Open Label, Multicenter Study to Evaluate Efficacy, Safety and Tolerability of a Self-Administered Subcutaneous Formulation of Icatibant for the Treatment of Acute Attacks of Hereditary Angioedema (IHA)
Primary Outcome Measures:
- Time to complete or near complete resolution from onset of symptoms [ Time Frame: Time to complete or near complete resolution of symptoms as reported by the patient, an expected average of 8-10 hours ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2014 (Final data collection date for primary outcome measure)
Placebo Comparator: Icatibant
30 mg subcutaneous dose of Icatibant
Other Name: Firazyr
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01457430
|San Diego Veterans Affairs Medical Center
|La Jolla, California, United States |
|UCLA - David Geffen School of Medicine
|Los Angeles, California, United States |
|Institute for Allergy and Asthma
|Wheaton, Maryland, United States, 20902 |
|Penn State University
|Hershey, Pennsylvania, United States, 17033 |
|AARA Research Center
|Dallas, Texas, United States, 75231 |
Massachusetts General Hospital
Shire Human Genetic Therapies, Inc.
||Aleena Banerji, M.D.
||Massachusetts General Hospital
No publications provided
||Aleena Banerji, MD, Assistant Professor of Medicine, Massachusetts General Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 13, 2011
||July 21, 2014
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 03, 2015
Genetic Diseases, Inborn
Immune System Diseases
Skin Diseases, Vascular
Anti-Inflammatory Agents, Non-Steroidal
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents