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Trial record 7 of 23 for:    ICATIBANT

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

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.
 
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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hereditary Angioedema
Intervention Drug: Icatibant
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Icatibant
Hide Arm/Group Description Icatibant: 30 mg subcutaneous dose of Icatibant
Period Title: Overall Study
Started 19
Completed 19
Not Completed 0
Arm/Group Title Icatibant
Hide Arm/Group Description Icatibant: 30 mg subcutaneous dose of Icatibant
Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
  89.5%
>=65 years
2
  10.5%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 19 participants
41
(19 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
14
  73.7%
Male
5
  26.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants
19
1.Primary Outcome
Title Time to Complete or Near Complete Resolution From Onset of Symptoms
Hide Description 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.
Time Frame Time to complete or near complete resolution of symptoms as reported by the patient, an expected average of 8-10 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Icatibant Treatment With Health Care Provider Icatibant Treatment by Self Administration
Hide Arm/Group Description:
Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by a health care provider.
Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by self administration.
Overall Number of Participants Analyzed 19 19
Median (Inter-Quartile Range)
Unit of Measure: minutes
735
(339 to 1563)
377
(220 to 618)
2.Secondary Outcome
Title Percent Change in VAS Scores
Hide Description Baseline, 4 hours VAS scale ranges from 0-100 with 0 being the lowest severity and 100 being the highest severity
Time Frame Percent Change in VAS Score from Baseline to 4 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Icatibant Treatment With Health Care Provider Icatibant Treatment by Self Administration
Hide Arm/Group Description:
Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by a health care provider.
Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by self administration.
Overall Number of Participants Analyzed 19 19
Median (Inter-Quartile Range)
Unit of Measure: percent change
-97
(-100 to -73)
-96
(-100 to -80)
Time Frame Adverse events were recorded throughout the study.
Adverse Event Reporting Description Adverse events were assessed out of total attacks, not total participants. There were 78 HAE attacks with data collected and recorded on adverse events.
 
Arm/Group Title Icatibant
Hide Arm/Group Description

Open-label study

Icatibant: 30 mg subcutaneous dose of Icatibant

All-Cause Mortality
Icatibant
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Icatibant
Affected / at Risk (%) # Events
Total   0/78 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Icatibant
Affected / at Risk (%) # Events
Total   4/78 (5.13%)    
Blood and lymphatic system disorders   
Fatigue  1/78 (1.28%)  1
Fever   1/78 (1.28%)  1
Gastrointestinal disorders   
Nausea  1/78 (1.28%)  1
Nervous system disorders   
Dizziness  1/78 (1.28%)  1
Indicates events were collected by systematic assessment
All adverse events were recorded and assessed out of total attacks, not total participants. There were 78 HAE attacks; 4 adverse events were identified.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Aleena Banerji
Organization: MGH Allergy Associates
Phone: 617-726-3850
EMail: abanerji@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Aleena Banerji, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01457430     History of Changes
Other Study ID Numbers: 2011P001768
First Submitted: October 13, 2011
First Posted: October 24, 2011
Results First Submitted: August 11, 2016
Results First Posted: October 18, 2016
Last Update Posted: October 18, 2016