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Trial record 13 of 20 for:    "Angioedema" | "Bradykinin"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00997204
Recruitment Status : Completed
First Posted : October 19, 2009
Results First Posted : July 28, 2014
Last Update Posted : July 28, 2014
Jerini AG
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE October 16, 2009
First Posted Date  ICMJE October 19, 2009
Results First Submitted Date  ICMJE November 4, 2013
Results First Posted Date  ICMJE July 28, 2014
Last Update Posted Date July 28, 2014
Study Start Date  ICMJE September 2009
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2014)
Number of Participants With Adverse Events in Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant [ Time Frame: 7 days from the beginning of each phase ]
Clinical safety of self-treatment of acute HAE attacks with s.c. injections of icatibant was assessed by calculating the number of AEs occurred during the study. Only those adverse events occurring up to the earlier of 7 days from the start of the naive phase, study discontinuation and start of the self-administration phase are assessed. The Local Tolerability Assessment tool was used. Subjects and Investigators graded erythema/reddening, swelling, burning, pruritus/itching, warm sensation, and skin pain on a 0 to 3 severity scale.
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2009)
Clinical safety of self-treatment of acute HAE attacks with s.c. injections of icatibant [ Time Frame: 48 hours post-dose ]
Change History Complete list of historical versions of study NCT00997204 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2014)
Clinical Efficacy of Self-treatment of Acute HAE Attacks With s.c. Injections of Icatibant, Time to Symptom Relief Using VAS Score for a Single Primary Symptom by Patient Cohort [ Time Frame: 48 hours post-dose ]
Subjects assessed angioedema attack symptoms using the visual analogue scale (VAS) for skin pain, skin swelling and abdominal pain. The VAS is a continuous scale comprised of a 100 mm in length line, anchored by 2 verbal descriptors, one for each symptom extreme 0 (no pain) and 100 (worst pain). The respondent is asked to place a mark on the VAS line (any where between 0 and 100 mm) at the point that represents their pain intensity. The score is determined by measuring the distance (mm) on the line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Score interpretation is: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). Symptom relief is defined as at least a 50% reduction in a pre-dose VAS score of 30 mm or greater. The time to onset of symptom relief is defined as the first of 3 consecutive assessments at which symptom relief was observed.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2009)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE EASSI - Evaluation of the Safety of Self-Administration With Icatibant
Official Title  ICMJE 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
Brief 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.
Detailed Description

This Phase IIIb study was multi-center and open-label with a single dose level. Subjects with a documented diagnosis of HAE Type I or II were eligible to participate in this trial. Eligible subjects included those who had received treatment for HAE with icatibant in previous clinical trials, or subjects who had been previously treated with the marketed product Firazyr® and subjects who were naïve to icatibant treatment.

All subjects were trained on the method of self-administration at their enrollment visit (Visit 1).For the training sessions, a syringe pre-filled with 3 mL placebo solution was used in place of icatibant. Comprehensive educational material and instructions including pictograms were developed for the subjects to illustrate the method of self-administration and use of the Patient Diary. The training material provided additional information on how to self-diagnose an HAE attack and how to decide on the necessity to treat.In addition, instructions were provided on what to do in case of a laryngeal attack.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hereditary Angioedema
Intervention  ICMJE Drug: Icatibant
Single subcutaneous injection of icatibant, 30 mg
Other Name: Brand name, Firazyr®
Study Arms  ICMJE
  • Experimental: Icatibant- Naive Treatment Phase
    Single subcutaneous injection of icatibant, 30 mg
    Intervention: Drug: Icatibant
  • Experimental: icatibant- Self administration Phase
    Single subcutaneous injection of icatibant, 30 mg
    Intervention: Drug: Icatibant
Publications * Aberer W, Maurer M, Reshef A, Longhurst H, Kivity S, Bygum A, Caballero T, Bloom B, Nair N, Malbrán A. Open-label, multicenter study of self-administered icatibant for attacks of hereditary angioedema. Allergy. 2014 Mar;69(3):305-14. doi: 10.1111/all.12303.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 30, 2014)
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2009)
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Austria,   Denmark,   France,   Germany,   Israel,   Italy,   Spain,   Switzerland,   United Kingdom
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00997204
Other Study ID Numbers  ICMJE JE049-3101
2008-000071-25 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shire
Study Sponsor  ICMJE Shire
Collaborators  ICMJE Jerini AG
Investigators  ICMJE
Study Director: Anja D. Lachmann, Dr. Jerini AG
PRS Account Shire
Verification Date June 2014

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