Efficacy, Safety and Tolerability of a Self-Administered Subcutaneous Formulation of Icatibant for the Treatment of Acute Attacks of Hereditary Angioedema (IHA)

This study is currently recruiting participants.
Verified June 2013 by Massachusetts General Hospital
Sponsor:
Collaborator:
Shire Human Genetic Therapies, Inc.
Information provided by (Responsible Party):
Aleena Banerji, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01457430
First received: October 13, 2011
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Hereditary Angioedema
Drug: Icatibant
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

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 ]

Estimated Enrollment: 30
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Icatibant
    30 mg subcutaneous dose of Icatibant
    Other Name: Firazyr
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females at least 18 years of age at the time of informed consent
  2. 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
  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 hereditary angioedema 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:

  1. Participation in a clinical therapeutic 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 hereditary angioedema.
  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 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 complete the patient diary, manage study medication or self-administration of an injection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01457430

Contacts
Contact: Ashley A Lopes 617-724-1714 alopes4@partners.org

Locations
United States, California
San Diego Veterans Affairs Medical Center Not yet recruiting
La Jolla, California, United States
Contact: Jennifer C Blair       jcblair@ucsd.edu   
Principal Investigator: Bruce Zuraw, MD         
UCLA - David Geffen School of Medicine Not yet recruiting
Los Angeles, California, United States
Contact: Carlos Torres-Garfias    310-206-2428    CTGarfias@mednet.ucla.edu   
Principal Investigator: Marc Riedl, MD, MS         
United States, Maryland
Institute for Allergy and Asthma Recruiting
Wheaton, Maryland, United States, 20902
Contact: Tamara Johnson, CCRC    301-962-1606      
Principal Investigator: Huamin Henry Li, MD, PhD         
United States, Pennsylvania
Penn State University Not yet recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Cathy Mende    717-531-4513    cmende@psu.edu   
Principal Investigator: Timothy Craig, DO         
United States, Texas
AARA Research Center Recruiting
Dallas, Texas, United States, 75231
Contact: Julie Tucker       jtucker@aararesearch.com   
Principal Investigator: William Lumry, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Shire Human Genetic Therapies, Inc.
Investigators
Principal Investigator: Aleena S Banerji, M.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Aleena Banerji, MD, Assistant Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01457430     History of Changes
Other Study ID Numbers: 2011P001768
Study First Received: October 13, 2011
Last Updated: June 11, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Angioedemas, Hereditary
Angioedema
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Genetic Diseases, Inborn
Icatibant
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 21, 2014