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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Shire Human Genetic Therapies, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Shire Human Genetic Therapies, Inc.
ClinicalTrials.gov Identifier:
NCT00997204
First received: October 16, 2009
Last updated: December 21, 2010
Last verified: December 2010
History of Changes

October 16, 2009
December 21, 2010
September 2009
January 2011   (final data collection date for primary outcome measure)
Clinical safety of self-treatment of acute HAE attacks with s.c. injections of icatibant [ Time Frame: 48 hours post-dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00997204 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
EASSI - Evaluation of the Safety of Self-Administration With Icatibant
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

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.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hereditary Angioedema
Drug: Icatibant
Single subcutaneous injection of icatibant, 30 mg
Experimental: Icatibant
Single subcutaneous injection of icatibant, 30 mg
Intervention: Drug: Icatibant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
June 2011
January 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Austria,   Denmark,   France,   Germany,   Israel,   Italy,   Spain,   Switzerland,   United Kingdom
 
NCT00997204
JE049-3101
No
Dr. Anja Lachmann, Jerini AG
Jerini AG
Not Provided
Study Director: Anja D. Lachmann, Dr. Jerini AG
Shire Human Genetic Therapies, Inc.
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP