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A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema

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ClinicalTrials.gov Identifier: NCT01386658
Recruitment Status : Completed
First Posted : July 1, 2011
Results First Posted : March 25, 2019
Last Update Posted : November 20, 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 32
Recruitment Details The study was conducted at 27 study centers in the United States, Germany, Israel, Spain, Argentina, Australia, Austria, Canada, Colombia, Hungary, and Italy between 27 January 2012 (first participant first visit) and 12 March 2018 (last participant last visit).
Pre-assignment Details A total of 32 participants were enrolled and received treatment.
Arm/Group Title Prepubertal Pubertal/Postpubertal
Hide Arm/Group Description Participants received a single subcutaneous (SC) injection of 0.4 milligram per kilogram (mg/kg) icatibant (up to a maximal dose of 30 mg) in the abdominal region. Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
Period Title: Initial Icatibant Exposure
Started 11 21
Completed 11 9
Not Completed 0 12
Reason Not Completed
Withdrawal by Subject             0             9
Lack of adherence and poor compliance             0             3
Period Title: Icatibant Exposure 2
Started 0 9
Completed 0 9
Not Completed 0 0
Period Title: Icatibant Exposure 3
Started 0 9
Completed 0 9
Not Completed 0 0
Arm/Group Title Prepubertal Pubertal/Postpubertal Total
Hide Arm/Group Description Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region. Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures. Total of all reporting groups
Overall Number of Baseline Participants 11 21 32
Hide Baseline Analysis Population Description
Safety population consisted of participants who were treated with icatibant at least once during the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 21 participants 32 participants
8.6  (2.97) 14.3  (1.66) 12.3  (3.48)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 21 participants 32 participants
Female
5
  45.5%
8
  38.1%
13
  40.6%
Male
6
  54.5%
13
  61.9%
19
  59.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 21 participants 32 participants
Hispanic or Latino
1
   9.1%
2
   9.5%
3
   9.4%
Not Hispanic or Latino
10
  90.9%
19
  90.5%
29
  90.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 21 participants 32 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
11
 100.0%
20
  95.2%
31
  96.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   4.8%
1
   3.1%
1.Primary Outcome
Title Time to Peak Concentration (Tmax) of a Single Subcutaneous (SC) Dose of Icatibant
Hide Description Time to peak concentration (Tmax) of a single SC dose of icatibant was reported.
Time Frame Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration-time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.
Arm/Group Title Prepubertal Pubertal/Postpubertal: With Acute Attack Pubertal/Postpubertal: Without Acute Attack
Hide Arm/Group Description:
Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants with acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants without acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Overall Number of Participants Analyzed 9 11 10
Mean (Standard Deviation)
Unit of Measure: Hour (h)
0.42  (0.13) 0.55  (0.19) 0.57  (0.17)
2.Primary Outcome
Title Maximum Plasma Concentration (Cmax) of a Single Subcutaneous (SC) Dose of Icatibant
Hide Description Maximum plasma concentration (Cmax) of a single SC dose of icatibant was reported.
Time Frame Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration-time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.
Arm/Group Title Prepubertal Pubertal/Postpubertal: With Acute Attack Pubertal/Postpubertal: Without Acute Attack
Hide Arm/Group Description:
Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants with acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants without acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Overall Number of Participants Analyzed 9 11 10
Mean (Standard Deviation)
Unit of Measure: Nanogram per milliliter (ng/mL)
659  (158) 805  (125) 761  (133)
3.Primary Outcome
Title Total Plasma Clearance (CL/F) of a Single Subcutaneous (SC) Dose of Icatibant
Hide Description Total plasma clearance (CL/F) of a single SC dose of icatibant was reported.
Time Frame Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.
Arm/Group Title Prepubertal Pubertal/Postpubertal: With Acute Attack Pubertal/Postpubertal: Without Acute Attack
Hide Arm/Group Description:
Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants with acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants without acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Overall Number of Participants Analyzed 6 11 10
Mean (Standard Deviation)
Unit of Measure: Milliliters per minute (mL/min)
10.8  (4.63) 13.1  (3.42) 19.3  (4.84)
4.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From Time Zero to 4 Hours Post-dose (AUC0-4) of a Single Subcutaneous (SC) Dose of Icatibant
Hide Description Area under the plasma concentration-time curve from time zero to 4 hours post-dose (AUC0-4) of a single SC dose of icatibant was reported.
Time Frame Pre-dose; 0.25, 0.5, 0.75, 1, 2, and 4 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.
Arm/Group Title Prepubertal Pubertal/Postpubertal: With Acute Attack Pubertal/Postpubertal: Without Acute Attack
Hide Arm/Group Description:
Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants with acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants without acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Overall Number of Participants Analyzed 9 11 10
Mean (Standard Deviation)
Unit of Measure: Hour*nanogram per milliliter (h*ng/mL)
1241  (319) 1448  (304) 1335  (211)
5.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From Time Zero to 6 Hours Post-dose (AUC0-t) of a Single Subcutaneous (SC) Dose of Icatibant
Hide Description Area under the plasma concentration-time curve from time zero to 6 hours post-dose (AUC0-t) of a single SC dose of icatibant was reported.
Time Frame Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.
Arm/Group Title Prepubertal Pubertal/Postpubertal: With Acute Attack Pubertal/Postpubertal: Without Acute Attack
Hide Arm/Group Description:
Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants with acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants without acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Overall Number of Participants Analyzed 9 11 10
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
1289  (325) 1573  (372) 1398  (225)
6.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of a Single Subcutaneous (SC) Dose of Icatibant
Hide Description Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of a single SC dose of icatibant was reported.
Time Frame Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.
Arm/Group Title Prepubertal Pubertal/Postpubertal: With Acute Attack Pubertal/Postpubertal: Without Acute Attack
Hide Arm/Group Description:
Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants with acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants without acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Overall Number of Participants Analyzed 6 11 10
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
1243  (244) 1710  (569) 1416  (229)
7.Primary Outcome
Title Volume of Distribution (Vz/F) of a Single Subcutaneous (SC) Dose of Icatibant
Hide Description Volume of distribution (Vz/F) of a single SC dose of icatibant was reported.
Time Frame Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.
Arm/Group Title Prepubertal Pubertal/Postpubertal: With Acute Attack Pubertal/Postpubertal: Without Acute Attack
Hide Arm/Group Description:
Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants with acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants without acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Overall Number of Participants Analyzed 6 11 10
Mean (Standard Deviation)
Unit of Measure: Liters (L)
12.5  (5.28) 23.5  (13.9) 25.4  (8.87)
8.Primary Outcome
Title Elimination Half-life (t1/2) of a Single Subcutaneous (SC) Dose of Icatibant
Hide Description Elimination half-life (t1/2) of a single SC dose of icatibant was reported.
Time Frame Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure.
Arm/Group Title Prepubertal Pubertal/Postpubertal: With Acute Attack Pubertal/Postpubertal: Without Acute Attack
Hide Arm/Group Description:
Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants with acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants without acute attack received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Overall Number of Participants Analyzed 6 11 10
Mean (Standard Deviation)
Unit of Measure: h
0.80  (0.04) 1.34  (0.96) 0.90  (0.10)
9.Primary Outcome
Title Number of Participants With Clinically Significant Changes in Vital Signs
Hide Description Vital signs included pulse rate, blood pressure, respiration rate, and temperature. The number of participants who reported clinically significant changes in vital signs were reported.
Time Frame Pre-dose up to 97 days post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population consisted of participants who were treated with icatibant at least once during the study.
Arm/Group Title Prepubertal Pubertal/Postpubertal
Hide Arm/Group Description:
Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
Overall Number of Participants Analyzed 11 21
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
10.Primary Outcome
Title Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs)
Hide Description A standard 12-lead ECG was performed after 10 minutes at rest when the participant was seated or supine following treatment. The number of participants who reported clinically significant changes in ECGs were reported.
Time Frame 6 - 8 hours post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population consisted of participants who were treated with icatibant at least once during the study.
Arm/Group Title Prepubertal Pubertal/Postpubertal
Hide Arm/Group Description:
Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
Overall Number of Participants Analyzed 11 21
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
11.Primary Outcome
Title Number of Participants With Clinically Significant Changes in Clinical Laboratory Evaluations
Hide Description Clinical laboratory evaluations included clinical chemistry (including liver function tests), hematology, urinalysis. The number of participants who reported clinically significant changes in clinical laboratory evaluations were reported.
Time Frame Pre-dose up to 97 days post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population consisted of participants who were treated with icatibant at least once during the study.
Arm/Group Title Prepubertal Pubertal/Postpubertal
Hide Arm/Group Description:
Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
Overall Number of Participants Analyzed 11 21
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
12.Primary Outcome
Title Number of Participants Who Reported Presence of Anti-icatibant Antibodies
Hide Description The number of participants who reported anti-icatibant antibodies were reported.
Time Frame Pre-dose up to 97 days post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population consisted of participants who were treated with icatibant at least once during the study.
Arm/Group Title Prepubertal Pubertal/Postpubertal
Hide Arm/Group Description:
Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
Overall Number of Participants Analyzed 11 21
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
13.Primary Outcome
Title Number of Participants With Adverse Events (AEs)
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 occurring in a clinical study, whether or not considered investigational product related.
Time Frame From the start of study drug administration up to 97 days post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population consisted of participants who were treated with icatibant at least once during the study.
Arm/Group Title Prepubertal Pubertal/Postpubertal
Hide Arm/Group Description:
Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
Overall Number of Participants Analyzed 11 21
Measure Type: Count of Participants
Unit of Measure: Participants
2
  18.2%
11
  52.4%
14.Primary Outcome
Title Number of Participants Who Reported Injection Site Reactions (ISR) for Icatibant Exposure Number 1
Hide Description The number of participants with injection site reactions (erythema, swelling, burning sensation, itching/pruritus, warm sensation, cutaneous pain, or other) that occured after initial icatibant administration was reported.
Time Frame 1 h post-dose on Day 1 up to 9 days post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population consisted of participants who were treated with icatibant at least once during the study. Here the number of participants analyzed signifies participants who were evaluable for this measure.
Arm/Group Title Prepubertal Pubertal/Postpubertal
Hide Arm/Group Description:
Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
Overall Number of Participants Analyzed 11 21
Measure Type: Count of Participants
Unit of Measure: Participants
Any Reaction
9
  81.8%
20
  95.2%
Any Severe Reaction
0
   0.0%
2
   9.5%
15.Primary Outcome
Title Number of Participants Who Reported Injection Site Reactions (ISR) for Icatibant Exposure Number 2 and 3
Hide Description The number of participants with injection site reactions (erythema, swelling, burning sensation, itching/pruritus, warm sensation, cutaneous pain, or other) that occurred after subsequent icatibant administration by study-site personnel (health care practitioner [HCP] administration) or by caregiver/self (caregiver administration) was reported. In the below table, E-2 refers to icatibant exposure 2 and E-3 refers to icatibant exposure 3.
Time Frame 1 h post-dose up to 9 days post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population consisted of participants who were treated with icatibant at least once during the study. Here the number of participants analyzed signifies participants who received subsequent icatibant exposures 2 and 3.
Arm/Group Title Pubertal/Postpubertal
Hide Arm/Group Description:
Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
E-2: HCP Administration: Any Reaction
1
  11.1%
E-2: HCP Administration: Any Severe Reaction
0
   0.0%
E-2: Caregiver Administration: Any Reaction
8
  88.9%
E-2: Caregiver Administration: Any Severe Reaction
3
  33.3%
E-3: HCP Administration: Any Reaction
1
  11.1%
E-3: HCP Administration: Any Severe Reaction
0
   0.0%
E-3: Caregiver Administration: Any Reaction
7
  77.8%
E-3: Caregiver Administration: Any Severe Reaction
1
  11.1%
16.Primary Outcome
Title Number of Participants With Clinically Significant Changes in Reproductive Hormones
Hide Description Reproductive hormone levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, and progesterone in females, and FSH, LH, and testosterone in males were measured. The number of participants with clinically significant changes in reproductive hormones was reported.
Time Frame Pre-dose up to 97 days post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population consisted of participants who were treated with icatibant at least once during the study.
Arm/Group Title Prepubertal Pubertal/Postpubertal
Hide Arm/Group Description:
Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
Overall Number of Participants Analyzed 11 21
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
17.Secondary Outcome
Title Time to Onset of Symptom Relief (TOSR) for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 1
Hide Description The TOSR was defined as the duration of time in hours from study drug administration to the earliest time post-treatment at which there was at least a 20 percent (%) improvement in the average post-treatment symptom score with no worsening of any single component score for the initial icatibant exposure. The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of hereditary angioedema (HAE) 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) and 4=very severe (very severe interference with daily activities). TOSR for participants who received initial icatibant administration was reported.
Time Frame From start of study drug administration up to 8.5 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who were evaluable for this measure.
Arm/Group Title Prepubertal Pubertal/Postpubertal
Hide Arm/Group Description:
Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
Overall Number of Participants Analyzed 11 11
Median (95% Confidence Interval)
Unit of Measure: h
1.0
(1.0 to 2.0)
1.0
(1.0 to 2.0)
18.Secondary Outcome
Title Time to Onset of Symptom Relief (TOSR) for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 2 and 3
Hide Description The TOSR was defined as the duration of time in hours from study drug administration to the earliest time post-treatment at which there was at least a 20% improvement in the composite (or average) post-treatment symptom score with no worsening of any single component score. The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE 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) and 4=very severe (very severe interference with daily activities). TOSR for participants who received subsequent icatibant administration by HCP administration or by caregiver/ self-administration was reported.
Time Frame From start of study drug administration up to 12 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who received subsequent icatibant exposures 2 and 3.
Arm/Group Title Pubertal/Postpubertal
Hide Arm/Group Description:
Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
Overall Number of Participants Analyzed 9
Median (95% Confidence Interval)
Unit of Measure: h
Icatibant Exposure-2: HCP Administration Number Analyzed 1 participants
4.0 [1] 
(NA to NA)
Icatibant Exposure-2: Caregiver Administration Number Analyzed 8 participants
1.0
(1.0 to 2.3)
Icatibant Exposure-3: HCP Administration Number Analyzed 1 participants
1.0 [2] 
(NA to NA)
Icatibant Exposure-3:Caregiver Administration Number Analyzed 7 participants
1.1
(1.0 to 3.0)
[1]
Percentage confidence interval (%CI) was not calculated due to less number of participants.
[2]
%CI was not calculated due to less number of participants.
19.Secondary Outcome
Title Time to Onset of Symptom Relief (TOSR) for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 1
Hide Description The TOSR was defined as the earliest time at which the post-treatment score improved by at least one level. Participants of 4 years age and older self-assessed their HAE-related pain using the FPS-R instrument. FPS-R is a self-reported measure used to assess the intensity of children's pain and it is scored using a 0 to 10 scale (0=no pain to 10=very much pain). TOSR for participants who received initial icatibant administration was reported.
Time Frame From start of study drug administration up to 52 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants with FPS-R data.
Arm/Group Title Prepubertal Pubertal/Postpubertal
Hide Arm/Group Description:
Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
Overall Number of Participants Analyzed 6 9
Median (95% Confidence Interval)
Unit of Measure: h
0.9
(0.8 to 1.0)
1.0
(0.6 to 1.0)
20.Secondary Outcome
Title Time to Onset of Symptom Relief (TOSR) for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 2 and 3
Hide Description The TOSR was defined as the earliest time at which the post-treatment score improved by at least one level. Participants of 4 years age and older self-assessed their HAE-related pain using the FPS-R instrument. FPS-R is a self-reported measure used to assess the intensity of children's pain and it is scored using a 0 to 10 scale (0=no pain to 10=very much pain). TOSR for participants who received subsequent icatibant administration by HCP administration or by caregiver/ self-administration was reported.
Time Frame From start of study drug administration up to 28 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants with FPS-R data.
Arm/Group Title Pubertal/Postpubertal
Hide Arm/Group Description:
Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
Overall Number of Participants Analyzed 9
Median (95% Confidence Interval)
Unit of Measure: h
Icatibant Exposure-2: HCP Administration Number Analyzed 1 participants
3.0 [1] 
(NA to NA)
Icatibant Exposure-2: Caregiver Administration Number Analyzed 7 participants
1.0
(1.0 to 1.2)
Icatibant Exposure-3: HCP Administration Number Analyzed 1 participants
1.0 [1] 
(NA to NA)
Icatibant Exposure-3:Caregiver Administration Number Analyzed 7 participants
1.1
(1.0 to 1.2)
[1]
%CI was not calculated due to less number of participants.
21.Secondary Outcome
Title Time to Onset of Symptom Relief (TOSR) for Faces, Legs, Activity, Cry, and Consolability (FLACC) Scores
Hide Description The TOSR was defined as the earliest time at which a 20% improvement was seen in the total post-treatment score. Participants of 4 years age and younger underwent investigator assessment of HAE-related pain (cutaneous, abdominal, and laryngeal) using the FLACC comportmental pain scale. Each of the 5 categories was scored from 0 to 2. Face(F): 0 (no particular expression/smile) - 2 (frequent to constant frown clenched jaw quivering chin); Legs(L): 0 (normal position/relaxed) - 2 (kicking/legs drawn up); Activity(A): 0 (lying quietly, normal position, moves easily) - 2 (arched rigid/jerking); Cry(C): 0 (No cry [awake/asleep]) - 2 (crying steadily/screams/sobs or frequent complaints); Consolability(C): 0 (content/relaxed) - 2 (difficult to console/comfort), resulting in a total score between 0 and 10.
Time Frame From start of study drug administration up to 8.5 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants of 4 years and younger with FLACC data.
Arm/Group Title Prepubertal
Hide Arm/Group Description:
Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Overall Number of Participants Analyzed 1
Median (95% Confidence Interval)
Unit of Measure: h
1.0 [1] 
(NA to NA)
[1]
%CI was not calculated due to less number of participants.
22.Secondary Outcome
Title Time to Minimum Symptoms for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 1
Hide Description Time to minimum symptom was defined as the duration of time in hours from study drug administration to the earliest time post-treatment at which all symptoms were either mild or absent for the investigator-reported symptom score. The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE 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) and 4=very severe (very severe interference with daily activities). Time to minimum symptom for participants who received initial icatibant administration was reported.
Time Frame From start of study drug administration up to 8.5 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who were evaluable for this measure.
Arm/Group Title Prepubertal Pubertal/Postpubertal
Hide Arm/Group Description:
Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
Overall Number of Participants Analyzed 11 10
Median (95% Confidence Interval)
Unit of Measure: h
1.9
(1.0 to 2.0)
1.0
(1.0 to 2.0)
23.Secondary Outcome
Title Time to Minimum Symptoms for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 2 and 3
Hide Description Time to minimum symptom was defined as the duration of time in hours from study drug administration to the earliest time post-treatment at which all symptoms were either mild or absent for the investigator-reported symptom score. The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE 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) and 4=very severe (very severe interference with daily activities). Time to minimum symptom for participants who received subsequent icatibant administration by HCP administration or by caregiver/ self-administration was reported.
Time Frame From start of study drug administration up to 12 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who were evaluable for this measure.
Arm/Group Title Pubertal/Postpubertal
Hide Arm/Group Description:
Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
Overall Number of Participants Analyzed 9
Median (95% Confidence Interval)
Unit of Measure: h
Icatibant Exposure-2: HCP Administration Number Analyzed 0 participants
Icatibant Exposure-2: Caregiver Administration Number Analyzed 7 participants
1.2
(1.0 to 2.0)
Icatibant Exposure-3: HCP Administration Number Analyzed 0 participants
Icatibant Exposure-3: Caregiver Administration Number Analyzed 7 participants
2.2 [1] 
(1.0 to NA)
[1]
The data was not calculated due to analysis method limitation.
24.Secondary Outcome
Title Time to Minimum Symptom for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 1
Hide Description Time to minimum symptoms was defined as the duration of time in hours from study drug administration to the earliest time at which post-treatment score improved to zero (or no pain). Participants of 4 years of age and older self-assessed their HAE-related pain using the FPS-R instrument. FPS-R is a self-reported measure used to assess the intensity of children's pain and it is scored using a 0 to 10 scale (0=no pain to 10=very much pain). Time to minimum symptom for participants who received initial icatibant administration was reported.
Time Frame From start of study drug administration up to 52 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants with FPS-R data.
Arm/Group Title Prepubertal Pubertal/Postpubertal
Hide Arm/Group Description:
Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
Overall Number of Participants Analyzed 6 11
Median (95% Confidence Interval)
Unit of Measure: h
2.4
(1.9 to 5.3)
3.8
(1.0 to 6.8)
25.Secondary Outcome
Title Time to Minimum Symptom for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 2 and 3
Hide Description Time to minimum symptoms was defined as the duration of time in hours from study drug administration to the earliest time at which post-treatment score improved to zero (or no pain). Participants of 4 years of age and older self-assessed their HAE-related pain using the FPS-R instrument. FPS-R is a self-reported measure used to assess the intensity of children's pain and it is scored using a 0 to 10 scale (0=no pain to 10=very much pain). Time to minimum symptom for participants who received subsequent icatibant administration by HCP administration or by caregiver/ self-administration was reported.
Time Frame From start of study drug administration up to 28 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants with FPS-R data.
Arm/Group Title Pubertal/Postpubertal
Hide Arm/Group Description:
Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
Overall Number of Participants Analyzed 9
Median (95% Confidence Interval)
Unit of Measure: h
Icatibant Exposure-2: HCP Administration Number Analyzed 1 participants
3.0 [1] 
(NA to NA)
Icatibant Exposure-2: Caregiver Administration Number Analyzed 7 participants
2.1
(1.0 to 4.0)
Icatibant Exposure-3: HCP Administration Number Analyzed 1 participants
5.8 [1] 
(NA to NA)
Icatibant Exposure-3:Caregiver Administration Number Analyzed 7 participants
24.0
(3.8 to 24.2)
[1]
The %CI was not calculated due to less number of participants.
26.Secondary Outcome
Title Time to Minimum Symptom for Faces, Legs, Activity, Cry, and Consolability (FLACC) Scores
Hide Description Time to minimum symptoms was defined as the duration of time in hours from study drug administration to the earliest time at which the total post-treatment score improved to zero. Participants of 4 years age and younger underwent investigator assessment of HAE-related pain (cutaneous, abdominal, and laryngeal) using the FLACC comportmental pain scale. Each of the 5 categories was scored from 0 to 2. (F) Face: 0 (no particular expression/smile) - 2 (frequent to constant frown clenched jaw quivering chin); (L) Legs: 0 (normal position/relaxed) - 2 (kicking/legs drawn up); (A) Activity: 0 (lying quietly, normal position, moves easily) - 2 (arched rigid/jerking); (C) Cry: 0 (No cry [awake/asleep]) - 2 (crying steadily/screams/sobs or frequent complaints); (C) Consolability: 0 (content/relaxed) - 2 (difficult to console/comfort), resulting in a total score between 0 and 10.
Time Frame From start of study drug administration up to 8.5 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from efficacy population with FLACC data.
Arm/Group Title Prepubertal
Hide Arm/Group Description:
Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Overall Number of Participants Analyzed 1
Median (95% Confidence Interval)
Unit of Measure: h
1.0 [1] 
(NA to NA)
[1]
The %CI was not calculated due to less number of participants.
27.Secondary Outcome
Title Time to Use of Rescue Medication for the Treatment of Symptoms of the Hereditary Angioedema (HAE) Attack Following Study Drug Administration
Hide Description Rescue medication was any medication used after the administration of icatibant which, in the opinion of the investigator, was immediately necessary to alleviate acute symptoms which are judged by the investigator as resultant from the current HAE attack. Time to first use of rescue medication prior to the onset of symptom relief was calculated from the time of study drug administration to the first use of rescue medication prior to the onset of symptom relief. This analysis was not performed since as per protocol, "This analysis will only be performed if there are at least 5 participants for a given attack who used rescue medication prior to attaining symptom relief".
Time Frame From the start of study drug administration up to 52 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who were evaluable for this measure.
Arm/Group Title Prepubertal Pubertal/Postpubertal
Hide Arm/Group Description:
Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
Overall Number of Participants Analyzed 11 11
Median (95% Confidence Interval)
Unit of Measure: h
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
This analysis was planned to be performed if there were at least 5 participants for a given attack who used rescue medication prior to attaining symptom relief.
28.Secondary Outcome
Title Number of Participants With Worsened Intensity of Clinical Hereditary Angioedema (HAE) Symptoms Between 2 and 4 Hours After Treatment With Icatibant Exposure Number 1
Hide Description The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE 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) and 4=very severe (very severe interference with daily activities). The number of participants with a worsened severity of HAE symptoms at 4 hours post-dose from 2 hours postdose were reported.
Time Frame From 2 hours post-dose to 4 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. Here the number of participants analyzed signifies participants who evaluable for this endpoint.
Arm/Group Title Prepubertal Pubertal/Postpubertal
Hide Arm/Group Description:
Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region.
Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
Overall Number of Participants Analyzed 11 11
Measure Type: Count of Participants
Unit of Measure: Participants
Abdominal Tenderness
0
   0.0%
1
   9.1%
Nausea
0
   0.0%
0
   0.0%
Vomiting
0
   0.0%
0
   0.0%
Diarrhea
0
   0.0%
0
   0.0%
Skin Pain
0
   0.0%
0
   0.0%
Erythema
0
   0.0%
0
   0.0%
Skin Irritation
0
   0.0%
0
   0.0%
Skin Swelling
0
   0.0%
0
   0.0%
29.Secondary Outcome
Title Number of Participants With Worsened Intensity of Clinical Hereditary Angioedema (HAE) Symptoms Between 2 and 4 Hours After Treatment With Icatibant Exposure Number 2 and 3
Hide Description The investigator used a symptom score to assess the severities of symptoms of acute cutaneous, abdominal, and laryngeal attacks of HAE 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) and 4=very severe (very severe interference with daily activities). The number of participants with a worsened severity of HAE symptoms at 4 hours post-dose from 2 hours post-dose were reported.
Time Frame From 2 hours post-dose to 4 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy population consisted of participants who were treated with icatibant for their first and any additional attacks during the study. The number of participants analyzed signifies participants evaluable for this endpoint.
Arm/Group Title Pubertal/Postpubertal
Hide Arm/Group Description:
Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
E-2: HCPA: Abdominal Tenderness Number Analyzed 1 participants
0
   0.0%
E-2:CA: Abdominal Tenderness Number Analyzed 8 participants
0
   0.0%
E-2: HCPA: Nausea Number Analyzed 1 participants
0
   0.0%
E-2: CA: Nausea Number Analyzed 8 participants
0
   0.0%
E-2:HCPA: Vomiting Number Analyzed 1 participants
0
   0.0%
E-2: CA: Vomiting Number Analyzed 8 participants
0
   0.0%
E-2: HCPA: Diarrhea Number Analyzed 1 participants
0
   0.0%
E-2: CA: Diarrhea Number Analyzed 8 participants
0
   0.0%
E-2: HCPA: Skin Pain Number Analyzed 1 participants
0
   0.0%
E-2: CA: Skin Pain Number Analyzed 8 participants
0
   0.0%
E-2: HCPA: Erythema Number Analyzed 1 participants
0
   0.0%
E-2: CA: Erythema Number Analyzed 8 participants
0
   0.0%
E-2: HCPA: Skin Irritation Number Analyzed 1 participants
0
   0.0%
E-2: CA: Skin Irritation Number Analyzed 8 participants
0
   0.0%
E-2: HCPA: Skin Swelling Number Analyzed 1 participants
0
   0.0%
E-2: CA: Skin Swelling Number Analyzed 8 participants
0
   0.0%
E-2: HCPA: Dysphagia Number Analyzed 1 participants
0
   0.0%
E-2: CA: Dysphagia Number Analyzed 8 participants
0
   0.0%
E-2: HCPA: Voice Change Number Analyzed 1 participants
0
   0.0%
E-2: CA: Voice Change Number Analyzed 8 participants
0
   0.0%
E-2: HCPA: Breathing Difficulties Number Analyzed 1 participants
0
   0.0%
E-2: CA: Breathing Difficulties Number Analyzed 8 participants
0
   0.0%
E-2: HCPA: Stridor Number Analyzed 1 participants
0
   0.0%
E-2: CA: Stridor Number Analyzed 8 participants
0
   0.0%
E-2: HCPA: Asphyxia Number Analyzed 1 participants
0
   0.0%
E-2:CA: Asphyxia Number Analyzed 8 participants
0
   0.0%
E-3: HCPA: Abdominal Tenderness Number Analyzed 1 participants
0
   0.0%
E-3: CA: Abdominal Tenderness Number Analyzed 8 participants
1
  12.5%
E-3: HCPA: Nausea Number Analyzed 1 participants
0
   0.0%
E-3: CA: Nausea Number Analyzed 8 participants
0
   0.0%
E-3: HCPA: Vomiting Number Analyzed 1 participants
0
   0.0%
E-3: CA: Vomiting Number Analyzed 8 participants
0
   0.0%
E-3: HCPA: Diarrhea Number Analyzed 1 participants
0
   0.0%
E-3: CA: Diarrhea Number Analyzed 8 participants
1
  12.5%
E-3: HCPA: Skin Pain Number Analyzed 1 participants
0
   0.0%
E-3: CA: Skin Pain Number Analyzed 8 participants
0
   0.0%
E-3: HCPA: Erythema Number Analyzed 1 participants
0
   0.0%
E-3: CA: Erythema Number Analyzed 8 participants
0
   0.0%
E-3: HCPA: Skin Irritation Number Analyzed 1 participants
0
   0.0%
E-3: CA: Skin Irritation Number Analyzed 8 participants
0
   0.0%
E-3: HCPA: Skin Swelling Number Analyzed 1 participants
0
   0.0%
E-3: CA: Skin Swelling Number Analyzed 8 participants
0
   0.0%
E-3: HCPA: Dysphagia Number Analyzed 1 participants
0
   0.0%
E-3: CA: Dysphagia Number Analyzed 8 participants
0
   0.0%
E-3: HCPA: Voice Change Number Analyzed 1 participants
0
   0.0%
E-3: CA: Voice Change Number Analyzed 8 participants
0
   0.0%
E-3: HCPA: Breathing Difficulties Number Analyzed 1 participants
0
   0.0%
E-3: CA: Breathing Difficulties Number Analyzed 8 participants
0
   0.0%
E-3: HCPA: Stridor Number Analyzed 1 participants
0
   0.0%
E-3: CA: Stridor Number Analyzed 8 participants
0
   0.0%
E-3: HCPA: Asphyxia Number Analyzed 1 participants
0
   0.0%
E-3: CA: Asphyxia Number Analyzed 8 participants
0
   0.0%
Time Frame From start of study drug administration up to 187 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prepubertal Pubertal/Post-pubertal Overall
Hide Arm/Group Description Participants received a single SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region. Participants received a SC injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region and participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures. Participants received a single subcutaneous(SC) injection of 0.4 mg/kg icatibant (up to a maximal dose of 30 mg) in the abdominal region. Pubertal/postpubertal participants after receiving initial treatment with icatibant, who subsequently experienced an acute hereditary angioedema (HAE) attack continued to receive treatment with icatibant as a single SC administration per attack for a total of 3 eligible icatibant exposures.
All-Cause Mortality
Prepubertal Pubertal/Post-pubertal Overall
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)      0/21 (0.00%)      0/32 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Prepubertal Pubertal/Post-pubertal Overall
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/21 (0.00%)      0/32 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Prepubertal Pubertal/Post-pubertal Overall
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/11 (36.36%)      8/21 (38.10%)      12/32 (37.50%)    
Blood and lymphatic system disorders       
Anaemia * 1  1/11 (9.09%)  1 0/21 (0.00%)  0 1/32 (3.13%)  1
Eye disorders       
Conjunctivitis * 1  0/11 (0.00%)  0 2/21 (9.52%)  5 2/32 (6.25%)  5
Conjunctivitis allergic * 1  0/11 (0.00%)  0 2/21 (9.52%)  9 2/32 (6.25%)  9
Gastrointestinal disorders       
Toothache * 1  0/11 (0.00%)  0 2/21 (9.52%)  2 2/32 (6.25%)  2
General disorders       
Pyrexia * 1  0/11 (0.00%)  0 2/21 (9.52%)  2 2/32 (6.25%)  2
Infections and infestations       
Nasopharyngitis * 1  0/11 (0.00%)  0 3/21 (14.29%)  4 3/32 (9.38%)  4
Upper respiratory tract infection * 1  1/11 (9.09%)  1 2/21 (9.52%)  3 3/32 (9.38%)  4
Injury, poisoning and procedural complications       
Epiphyseal fracture * 1  1/11 (9.09%)  1 0/21 (0.00%)  0 1/32 (3.13%)  1
Thermal burn * 1  1/11 (9.09%)  1 0/21 (0.00%)  0 1/32 (3.13%)  1
Investigations       
Nitrite urine present * 1  1/11 (9.09%)  1 0/21 (0.00%)  0 1/32 (3.13%)  1
Metabolism and nutrition disorders       
Dehydration * 1  1/11 (9.09%)  1 0/21 (0.00%)  0 1/32 (3.13%)  1
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  1/11 (9.09%)  1 0/21 (0.00%)  0 1/32 (3.13%)  1
Nervous system disorders       
Headache * 1  1/11 (9.09%)  2 1/21 (4.76%)  1 2/32 (6.25%)  3
Respiratory, thoracic and mediastinal disorders       
Bronchospasm * 1  1/11 (9.09%)  2 0/21 (0.00%)  0 1/32 (3.13%)  2
Oropharyngeal pain * 1  0/11 (0.00%)  0 2/21 (9.52%)  2 2/32 (6.25%)  2
1
Term from vocabulary, MedDRA 16.0
*
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: NCT01386658     History of Changes
Other Study ID Numbers: HGT-FIR-086
2011-003825-81 ( EudraCT Number )
First Submitted: June 28, 2011
First Posted: July 1, 2011
Results First Submitted: February 14, 2019
Results First Posted: March 25, 2019
Last Update Posted: November 20, 2019