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A Study of Icatibant for Acute Attacks of Hereditary Angioedema in Japanese Participants

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ClinicalTrials.gov Identifier: NCT03888755
Recruitment Status : Completed
First Posted : March 25, 2019
Results First Posted : August 8, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hereditary Angioedema (HAE)
Intervention Drug: Icatibant
Enrollment 8
Recruitment Details The study was conducted at 8 sites in Japan between 18 March 2015 (first participant first visit) and 12 February 2016 (last participant last visit).
Pre-assignment Details A total of 8 Japanese participants were enrolled and included in the study treatment.
Arm/Group Title Icatibant
Hide Arm/Group Description Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 milligram (mg) subcutaneous (SC) injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title Icatibant
Hide Arm/Group Description Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 milligram (mg) subcutaneous (SC) injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
The treated population included all participants treated with icatibant.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
45.5  (16.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
5
  62.5%
Male
3
  37.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
American Indian or Alaska Native
0
   0.0%
Asian
8
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Time to Onset of Symptom Relief (TOSR)
Hide Description The TOSR was defined as a 50 percent (%) reduction from the pre-treatment score in the 3-symptom composite VAS score for non-laryngeal attacks and 5-symptom composite VAS score for laryngeal attacks. A VAS utilizes a scale consisting of a 100 millimeter (mm) horizontal line with extreme values at the beginning (0 mm = no symptom) and end (100 mm = worst possible symptom) of the line. The participant should draw a vertical line at the point along the scale that represents the current status of the measured symptom. Composite VAS scores were calculated as the average of VAS measurements for skin swelling, skin pain, and abdominal pain (3-symptom composite) for non-laryngeal attacks and for skin swelling, skin pain, abdominal pain, difficulty swallowing, and voice change (5-symptom composite) for laryngeal attacks.
Time Frame Baseline up to 120 hours post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The treated population included all participants treated with icatibant
Arm/Group Title Icatibant
Hide Arm/Group Description:
Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 milligram (mg) subcutaneous (SC) injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
Overall Number of Participants Analyzed 8
Median (95% Confidence Interval)
Unit of Measure: Hours
1.75
(1.00 to 2.50)
2.Secondary Outcome
Title Time to Onset of Primary Symptom Relief (TOSR-P)
Hide Description Primary symptom relief was based on the participant-assessed VAS score for a single primary symptom (determined by edema location) and corresponds to a reduction by 31 mm at a pretreatment VAS of 100 mm and by 21 mm at a pretreatment VAS of 30 mm. If the primary symptom pretreatment VAS less than (<) 30 mm, then primary symptom relief was defined as 68% reduction from pretreatment. A VAS utilizes a scale consisting of a 100 millimeter (mm) horizontal line with extreme values at the beginning (0 mm = no symptom) and end (100 mm = worst possible symptom) of the line. The TOSR-P was calculated from the time of icatibant administration to the onset of primary symptom relief.
Time Frame Baseline up to 120 hours post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The treated population included all participants treated with icatibant
Arm/Group Title Icatibant
Hide Arm/Group Description:
Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 mg SC injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
Overall Number of Participants Analyzed 8
Median (95% Confidence Interval)
Unit of Measure: Hours
1.07
(1.00 to 2.00)
3.Secondary Outcome
Title Change From Baseline in the Composite Visual Analog Scale (VAS) Score
Hide Description A VAS utilizes a scale consisting of a 100 mm horizontal line with extreme values at the beginning (0 mm = no symptom) and end (100 mm = worst possible symptom) of the line. The participant should draw a vertical line at the point along the scale that represents the current status of the measured symptom. Composite VAS scores was calculated as the average of VAS measurements for skin swelling, skin pain, abdominal pain, difficulty swallowing, and voice change (5-symptom composite) for laryngeal attacks and as the average of VAS measurements for skin swelling, skin pain and abdominal pain (3-symptom composite) for non-laryngeal attacks. Change from baseline in the composite VAS score was reported.
Time Frame Baseline, 2, 4 and 8 hours post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The treated population included all participants treated with icatibant
Arm/Group Title Icatibant
Hide Arm/Group Description:
Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 mg SC injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline 30.78  (13.465)
2 hours -19.26  (13.310)
4 hours -24.57  (13.367)
8 hours -29.40  (12.998)
4.Secondary Outcome
Title Composite Symptom Score (SS) Assessed by Investigator
Hide Description The investigator-assessed composite symptom score was calculated as an average of abdominal tenderness, nausea, vomiting, diarrhea, skin pain, erythema, skin irritation, and skin swelling (8 symptoms) for non-laryngeal attacks and the average of abdominal tenderness, nausea, vomiting, diarrhea, skin pain, erythema, skin irritation, skin swelling, dysphagia, voice change, breathing difficulties, stridor, and asphyxia (13 symptoms) for laryngeal attacks using the following 5-point scale 0 = none (absence of symptoms); 1 = mild (no to mild interference with daily activities); 2 = moderate (moderate interference with daily activities); 3 = severe (severe interference with daily activities); 4 = very severe (very severe interference with daily activities). Here the composite SS assessed by investigator was reported.
Time Frame 8 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
The treated population included all participants treated with icatibant
Arm/Group Title Icatibant
Hide Arm/Group Description:
Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 mg SC injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Score on a scale
0.12  (0.18)
5.Secondary Outcome
Title Composite Symptom Score (SS) Assessed by Participant
Hide Description The participant-assessed composite symptom score was calculated as an average of abdominal pain, nausea, vomiting, diarrhea, skin pain, erythema, skin irritation, and skin swelling (8 symptoms) for non-laryngeal attacks and the average of abdominal pain, nausea, vomiting, diarrhea, skin pain, erythema,skin irritation, skin swelling, dysphagia and voice change (10 symptoms) for laryngeal attacks using the following 5-point scale 0 = none (absence of symptoms); 1 = mild (no to mild interference with daily activities); 2 = moderate (moderate interference with daily activities); 3 = severe (severe interference with daily activities); 4 = very severe (very severe interference with daily activities). Here the composite SS assessed by participant was reported.
Time Frame 8 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
The treated population included all participants treated with icatibant
Arm/Group Title Icatibant
Hide Arm/Group Description:
Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 mg SC injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Score on a scale
0.14  (0.16)
6.Secondary Outcome
Title Investigator Global Assessment
Hide Description The investigator was made a global assessment (that is [i.e.] consideration of all abdominal symptoms combined, all cutaneous symptoms combined and/or all laryngeal symptoms combined) using the following 5-point scale, where the symptoms were scored from 0 for “absence of symptoms” to 4 for “very severe”: 0 = none (absence of symptoms); 1 = mild (no to mild interference with daily activities); 2 = moderate (moderate interference with daily activities); 3 = severe (severe interference with daily activities); 4 = very severe (very severe interference with daily activities).
Time Frame 2, 4 and 8 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
The treated population included all participants who received one dose of icatibant.
Arm/Group Title Icatibant
Hide Arm/Group Description:
Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 mg SC injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart could have been given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Cutaneous Symptoms: 2 hours (h) post dose 0.9  (0.99)
Cutaneous Symptoms: 4 h post dose 0.6  (0.52)
Cutaneous Symptoms: 8 h post dose 0.5  (0.53)
Abdominal Symptoms: 2 h post dose 0.1  (0.35)
Abdominal Symptoms: 4 h post dose 0.0  (0.00)
Abdominal Symptoms: 8 h post dose 0.0  (0.00)
Laryngeal Symptoms: 2 h post dose 0.0  (0.00)
Laryngeal Symptoms: 4 h post dose 0.0  (0.00)
Laryngeal Symptoms: 8 h post dose 0.0  (0.00)
7.Secondary Outcome
Title Time to Initial Symptom Improvement by Investigator
Hide Description Time to initial symptom improvement was evaluated by the investigator; each were asked to record the time at which they perceived initial improvement of symptoms. Time to initial symptom improvement was calculated from the time of icatibant administration to the time reported by the investigator of initial improvement of symptoms.
Time Frame Baseline up to 120 hours post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The treated population included all participants treated with icatibant
Arm/Group Title Icatibant
Hide Arm/Group Description:
Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 mg SC injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
Overall Number of Participants Analyzed 8
Median (95% Confidence Interval)
Unit of Measure: H
0.98
(0.30 to 2.00)
8.Secondary Outcome
Title Time to Initial Symptom Improvement by Participants
Hide Description Time to initial symptom improvement was evaluated by the participants; each were asked to record the time at which they perceived initial improvement of symptoms. Time to initial symptom improvement was calculated from the time of icatibant administration to the time reported by the participant of initial improvement of symptoms.
Time Frame Baseline up to 120 hours post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The treated population included all participants treated with icatibant.
Arm/Group Title Icatibant
Hide Arm/Group Description:
Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 mg SC injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
Overall Number of Participants Analyzed 8
Median (95% Confidence Interval)
Unit of Measure: h
1.04
(0.30 to 2.05)
9.Secondary Outcome
Title Time to Almost Complete Symptom Relief As Assessed by Visual Analog Scale (VAS) Score
Hide Description Time to almost complete symptom relief was calculated from the time of icatibant administration to almost complete symptom relief. Almost complete symptom relief was determined retrospectively as the earliest of three consecutive non-missing measurements for which all VAS scores < 10 mm. A VAS utilizes a scale consisting of a 100 millimeter (mm) horizontal line with extreme values at the beginning (0 mm = no symptom) and end (100 mm = worst possible symptom) of the line. The participant should draw a vertical line at the point along the scale that represents the current status of the measured symptom.
Time Frame Baseline up to 120 hours post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The treated population included all participants treated with icatibant
Arm/Group Title Icatibant
Hide Arm/Group Description:
Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 mg SC injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
Overall Number of Participants Analyzed 8
Median (Inter-Quartile Range)
Unit of Measure: H
5.98
(2.27 to 8.00)
10.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Icatibant After a Single Subcutaneous (SC) Administration of Icatibant
Hide Description The Cmax was estimated by a population PK modeling approach. The Cmax of icatibant was reported.
Time Frame Baseline, 0.75, 2 hours post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) analysis population included all participants who received study drug and provided evaluable plasma drug concentrations.
Arm/Group Title Icatibant
Hide Arm/Group Description:
Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 mg SC injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Nano grams per milliliter (ng/mL)
405  (194)
11.Secondary Outcome
Title Area Under the Concentration-time Curve From 0 to 2 Hours (AUC0-2) After a Single Subcutaneous (SC) Administration of Icatibant
Hide Description The AUC0-2 was estimated by a population PK modeling approach. The AUC0-2 of Icatibant was reported.
Time Frame Baseline, 0.75, 2 hours post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis population included all participants who received study drug and provided evaluable plasma drug concentrations.
Arm/Group Title Icatibant
Hide Arm/Group Description:
Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 mg SC injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: Nanograms*hour per milliliter (ng•h/mL)
611  (338)
12.Secondary Outcome
Title Area Under the Concentration-time Curve From 0 to 4 Hours (AUC0-4) After a Single Subcutaneous (SC) Administration of Icatibant
Hide Description The AUC0-4 was estimated by a population PK modeling approach. The AUC0-4 of Icatibant was reported.
Time Frame Baseline, 0.75, 2 hours post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis population included all participants who received study drug and provided evaluable plasma drug concentrations.
Arm/Group Title Icatibant
Hide Arm/Group Description:
Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 mg SC injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: ng•h/mL
1198  (495)
13.Secondary Outcome
Title Area Under the Concentration-time Curve From 0 to 6 Hours (AUC0-6) After a Single Subcutaneous (SC) Administration of Icatibant
Hide Description The AUC0-6 was estimated by a population PK modeling approach. The AUC0-6 of Icatibant was reported.
Time Frame Baseline, 0.75, 2 hours post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis population included all participants who received study drug and provided evaluable plasma drug concentrations.
Arm/Group Title Icatibant
Hide Arm/Group Description:
Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 mg SC injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: ng•h/mL
1506  (509)
14.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Hide Description An AE was any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurred in any phase of a clinical study, whether or not considered investigational product related. The TEAEs were defined as all AEs occurred on or after the time of study drug administration.
Time Frame From start of study drug administration to follow-up (up to 10 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The treated population included all participants treated with icatibant
Arm/Group Title Icatibant
Hide Arm/Group Description:
Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 mg SC injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
3
  37.5%
15.Secondary Outcome
Title Number of Participants With Injection Site Reactions Reported as Adverse Event (AE)
Hide Description Number of participants with injection site reactions (erythema, swelling, cutaneous pain, burning sensation, itching/pruritus, and warm sensation) were reported.
Time Frame From start of study drug administration to follow-up (up to 10 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The treated population included all participants treated with icatibant
Arm/Group Title Icatibant
Hide Arm/Group Description:
Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 mg SC injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
Any Reaction
7
  87.5%
Any Severe Reaction
1
  12.5%
16.Secondary Outcome
Title Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests Reported as Adverse Event (AE)
Hide Description Clinical laboratory tests included serum chemistry, hematology, urinalysis and coagulation were assessed. Number of participants with clinically significant changes in clinical laboratory tests were reported.
Time Frame From start of study drug administration to follow-up (up to 10 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The treated population included all participants treated with icatibant
Arm/Group Title Icatibant
Hide Arm/Group Description:
Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 mg SC injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
17.Secondary Outcome
Title Number of Participants With Clinically Significant Changes in Vital Signs Reported as Adverse Event (AE)
Hide Description Vital signs included pulse rate, blood pressure, respiration rate, and temperature. The number of participants with clinically significant changes in vital signs were reported.
Time Frame From start of study drug administration to follow-up (up to 10 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The treated population included all participants treated with icatibant
Arm/Group Title Icatibant
Hide Arm/Group Description:
Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 mg SC injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
18.Secondary Outcome
Title Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as Adverse Event (AE)
Hide Description A standard 12-lead ECG was performed. The number of participants who reported clinically significant changes in ECGs were reported.
Time Frame From start of study drug administration to follow-up (up to 10 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The treated population included all participants treated with icatibant
Arm/Group Title Icatibant
Hide Arm/Group Description:
Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 mg SC injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame From start of study drug administration to 10 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Icatibant
Hide Arm/Group Description Participants with 1 acute non-laryngeal or laryngeal attack received a single icatibant 30 milligram (mg) subcutaneous (SC) injection in the abdominal area. A maximum of 3 SC injections (or 90 mg) of icatibant that were at least 6 hours apart were given for treatment of an attack if, within 48 hours of the initial treatment, there was insufficient relief or worsening of symptoms.
All-Cause Mortality
Icatibant
Affected / at Risk (%)
Total   0/8 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Icatibant
Affected / at Risk (%) # Events
Total   0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Icatibant
Affected / at Risk (%) # Events
Total   3/8 (37.50%)    
Congenital, familial and genetic disorders   
HEREDITARY ANGIOEDEMA * 1  2/8 (25.00%)  2
Nervous system disorders   
HEADACHE * 1  1/8 (12.50%)  1
1
Term from vocabulary, MedDRA 16.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Shire
Phone: +1 866 842 5335
EMail: ClinicalTransparency@shire.com
Layout table for additonal information
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT03888755     History of Changes
Other Study ID Numbers: SHP-FIR-301
First Submitted: March 20, 2019
First Posted: March 25, 2019
Results First Submitted: March 25, 2019
Results First Posted: August 8, 2019
Last Update Posted: September 17, 2019