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Efficacy, Safety and Tolerability of Icatibant for the Treatment of HAE (IHA)

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ClinicalTrials.gov Identifier: NCT01457430
Recruitment Status : Completed
First Posted : October 24, 2011
Results First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Sponsor:
Collaborator:
Shire Human Genetic Therapies, Inc.
Information provided by (Responsible Party):
Aleena Banerji, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE October 13, 2011
First Posted Date  ICMJE October 24, 2011
Results First Submitted Date  ICMJE August 11, 2016
Results First Posted Date  ICMJE October 18, 2016
Last Update Posted Date October 18, 2016
Study Start Date  ICMJE December 2011
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
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 ]
Time of onset of HAE attack, time icatibant was administered, and time to complete relief of symptoms were recorded in minutes. Time to complete relief of symptoms was defined as time from onset of symptoms to complete or near complete resolution as reported by the patient.
Original Primary Outcome Measures  ICMJE
 (submitted: October 20, 2011)
Time to Complete or Near Complete Resolution From Onset of Symptoms [ Time Frame: Time of complete or near complete improvement of symptoms as reported by the patient ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
Percent Change in VAS Scores [ Time Frame: Percent Change in VAS Score from Baseline to 4 Hours ]
Baseline, 4 hours VAS scale ranges from 0-100 with 0 being the lowest severity and 100 being the highest severity
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy, Safety and Tolerability of Icatibant for the Treatment of HAE
Official Title  ICMJE 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)
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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hereditary Angioedema
Intervention  ICMJE Drug: Icatibant
30 mg subcutaneous dose of Icatibant
Other Name: Firazyr
Study Arms  ICMJE Experimental: Icatibant
Open-label study
Intervention: Drug: Icatibant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 17, 2016)
19
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2011)
30
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01457430
Other Study ID Numbers  ICMJE 2011P001768
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: The data is under review for publication but individual data will likely not be available
Responsible Party Aleena Banerji, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Shire Human Genetic Therapies, Inc.
Investigators  ICMJE
Principal Investigator: Aleena Banerji, M.D. Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date October 2016

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