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The objective of this study is to evaluate the efficacy, pharmacokinetics (PK), and safety of icatibant for the treatment of acute attacks in Japanese participants with type I or type II hereditary angioedema (HAE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Icatibant | Experimental | Participants with 1 acute non-laryngeal or laryngeal attack will receive 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 are at least 6 hours apart can be given for treatment of an attack if, within 48 hours of the initial treatment, there is insufficient relief or worsening of symptoms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Icatibant | Drug | Participants will receive icatibant 30 mg SC injection in the abdominal area. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Onset of Symptom Relief (TOSR) | 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. | Baseline up to 120 hours post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Onset of Primary Symptom Relief (TOSR-P) | 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. |
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Inclusion Criteria:
The participant is in Japan and is Japanese; defined as born in Japan and having Japanese parents and Japanese maternal and paternal grandparents.
The participant is male or female and greater than or equal to (>=) 18 years of age at the time of informed consent.
The participant has a confirmed diagnosis of hereditary angioedema (HAE) type I or II. Diagnosis may be based on historical data using the following criteria:
If the participant does not have a confirmed diagnosis of HAE type I or II based on historical data, including C1-INH deficiency, the participant's diagnosis must be determined prior to treatment by C1-NH test results which demonstrate a quantitative and/or functional C1-INH deficiency.
The current HAE attack must be in the cutaneous, abdominal, and/or laryngeal (inclusive of laryngeal and pharyngeal) areas.
The attack must be moderate to severe for non-laryngeal and mild to moderate for laryngeal as determined by investigator global assessment at pretreatment (baseline).
The participant commences treatment within 6 hours of the attack becoming at least mild (laryngeal) or moderate (non-laryngeal) in severity, but not more than 12 hours (h) after the onset of the attack. Note: for participant who present to the hospital/clinic with symptoms which have already progressed to at least moderate (non-laryngeal) or mild (laryngeal) severity, their duration can be estimated by the investigator through questioning of the participant.
The participant (or the participant's parent/legal guardian, if applicable) has provided written informed consent which has been approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC).
Females of childbearing potential must have a negative urine pregnancy test and must use medically acceptable methods to prevent pregnancy during their active participation in the study, (time from icatibant treatment of the acute attack to the follow-up visit at Day 7 [+3 days]), with the exception of those females who have had a total hysterectomy or bilateral oophorectomy, or who are 2 years post menopausal.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukushima Medical University Hospital | Fukushima | Japan | ||||
| Hiroshima University Hospital |
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
A total of 8 Japanese participants were enrolled and included in the study treatment.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Icatibant | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The treated population included all participants treated with icatibant.
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| ID | Title | Description |
|---|---|---|
| BG000 | Icatibant | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Onset of Symptom Relief (TOSR) | 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. | The treated population included all participants treated with icatibant | Posted | Median | 95% Confidence Interval | Hours | Baseline up to 120 hours post-treatment |
|
From start of study drug administration to 10 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Icatibant | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HEREDITARY ANGIOEDEMA | Congenital, familial and genetic disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
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| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| ID | Term |
|---|---|
| D000799 | Angioedema |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000081208 | Hereditary Complement Deficiency Diseases |
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| ID | Term |
|---|---|
| C065679 | icatibant |
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| Baseline up to 120 hours post-treatment |
| Change From Baseline in the Composite Visual Analog Scale (VAS) Score | 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. | Baseline, 2, 4 and 8 hours post-treatment |
| Composite Symptom Score (SS) Assessed by Investigator | 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. | 8 hours post dose |
| Composite Symptom Score (SS) Assessed by Participant | 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. | 8 hours post dose |
| Investigator Global Assessment | 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). | 2, 4 and 8 hours post dose |
| Time to Initial Symptom Improvement by Investigator | 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. | Baseline up to 120 hours post-treatment |
| Time to Initial Symptom Improvement by Participants | 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. | Baseline up to 120 hours post-treatment |
| Time to Almost Complete Symptom Relief As Assessed by Visual Analog Scale (VAS) Score | 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. | Baseline up to 120 hours post-treatment |
| Maximum Observed Plasma Concentration (Cmax) of Icatibant After a Single Subcutaneous (SC) Administration of Icatibant | The Cmax was estimated by a population PK modeling approach. The Cmax of icatibant was reported. | Baseline, 0.75, 2 hours post-treatment |
| Area Under the Concentration-time Curve From 0 to 2 Hours (AUC0-2) After a Single Subcutaneous (SC) Administration of Icatibant | The AUC0-2 was estimated by a population PK modeling approach. The AUC0-2 of Icatibant was reported. | Baseline, 0.75, 2 hours post-treatment |
| Area Under the Concentration-time Curve From 0 to 4 Hours (AUC0-4) After a Single Subcutaneous (SC) Administration of Icatibant | The AUC0-4 was estimated by a population PK modeling approach. The AUC0-4 of Icatibant was reported. | Baseline, 0.75, 2 hours post-treatment |
| Area Under the Concentration-time Curve From 0 to 6 Hours (AUC0-6) After a Single Subcutaneous (SC) Administration of Icatibant | The AUC0-6 was estimated by a population PK modeling approach. The AUC0-6 of Icatibant was reported. | Baseline, 0.75, 2 hours post-treatment |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. | From start of study drug administration to follow-up (up to 10 days) |
| Number of Participants With Injection Site Reactions Reported as Adverse Event (AE) | Number of participants with injection site reactions (erythema, swelling, cutaneous pain, burning sensation, itching/pruritus, and warm sensation) were reported. | From start of study drug administration to follow-up (up to 10 days) |
| Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests Reported as Adverse Event (AE) | 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. | From start of study drug administration to follow-up (up to 10 days) |
| Number of Participants With Clinically Significant Changes in Vital Signs Reported as Adverse Event (AE) | Vital signs included pulse rate, blood pressure, respiration rate, and temperature. The number of participants with clinically significant changes in vital signs were reported. | From start of study drug administration to follow-up (up to 10 days) |
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as Adverse Event (AE) | A standard 12-lead ECG was performed. The number of participants who reported clinically significant changes in ECGs were reported. | From start of study drug administration to follow-up (up to 10 days) |
| Hiroshima |
| Japan |
| Kobe University Hospital | Kobe | Japan |
| Saiseikai Kumamoto Hospital | Kumamoto | Japan |
| Niigata City General Hospital | Niigata | Japan |
| Nihon University Itabashi Hospital | Tokyo | Japan |
| Tomakomai City Hospital | Tomakomai | Japan |
| Yokohama City University Hospital | Yokohama | Japan |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Icatibant |
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. |
|
|
| Secondary | Time to Onset of Primary Symptom Relief (TOSR-P) | 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. | The treated population included all participants treated with icatibant | Posted | Median | 95% Confidence Interval | Hours | Baseline up to 120 hours post-treatment |
|
|
|
| Secondary | Change From Baseline in the Composite Visual Analog Scale (VAS) Score | 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. | The treated population included all participants treated with icatibant | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 2, 4 and 8 hours post-treatment |
|
|
|
| Secondary | Composite Symptom Score (SS) Assessed by Investigator | 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. | The treated population included all participants treated with icatibant | Posted | Mean | Standard Deviation | Score on a scale | 8 hours post dose |
|
|
|
| Secondary | Composite Symptom Score (SS) Assessed by Participant | 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. | The treated population included all participants treated with icatibant | Posted | Mean | Standard Deviation | Score on a scale | 8 hours post dose |
|
|
|
| Secondary | Investigator Global Assessment | 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). | The treated population included all participants who received one dose of icatibant. | Posted | Mean | Standard Deviation | Score on a scale | 2, 4 and 8 hours post dose |
|
|
|
| Secondary | Time to Initial Symptom Improvement by Investigator | 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. | The treated population included all participants treated with icatibant | Posted | Median | 95% Confidence Interval | H | Baseline up to 120 hours post-treatment |
|
|
|
| Secondary | Time to Initial Symptom Improvement by Participants | 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. | The treated population included all participants treated with icatibant. | Posted | Median | 95% Confidence Interval | h | Baseline up to 120 hours post-treatment |
|
|
|
| Secondary | Time to Almost Complete Symptom Relief As Assessed by Visual Analog Scale (VAS) Score | 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. | The treated population included all participants treated with icatibant | Posted | Median | Inter-Quartile Range | H | Baseline up to 120 hours post-treatment |
|
|
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Icatibant After a Single Subcutaneous (SC) Administration of Icatibant | The Cmax was estimated by a population PK modeling approach. The Cmax of icatibant was reported. | The pharmacokinetic (PK) analysis population included all participants who received study drug and provided evaluable plasma drug concentrations. | Posted | Mean | Standard Deviation | Nano grams per milliliter (ng/mL) | Baseline, 0.75, 2 hours post-treatment |
|
|
|
| Secondary | Area Under the Concentration-time Curve From 0 to 2 Hours (AUC0-2) After a Single Subcutaneous (SC) Administration of Icatibant | The AUC0-2 was estimated by a population PK modeling approach. The AUC0-2 of Icatibant was reported. | The PK analysis population included all participants who received study drug and provided evaluable plasma drug concentrations. | Posted | Mean | Standard Deviation | Nanograms*hour per milliliter (ng•h/mL) | Baseline, 0.75, 2 hours post-treatment |
|
|
|
| Secondary | Area Under the Concentration-time Curve From 0 to 4 Hours (AUC0-4) After a Single Subcutaneous (SC) Administration of Icatibant | The AUC0-4 was estimated by a population PK modeling approach. The AUC0-4 of Icatibant was reported. | The PK analysis population included all participants who received study drug and provided evaluable plasma drug concentrations. | Posted | Mean | Standard Deviation | ng•h/mL | Baseline, 0.75, 2 hours post-treatment |
|
|
|
| Secondary | Area Under the Concentration-time Curve From 0 to 6 Hours (AUC0-6) After a Single Subcutaneous (SC) Administration of Icatibant | The AUC0-6 was estimated by a population PK modeling approach. The AUC0-6 of Icatibant was reported. | The PK analysis population included all participants who received study drug and provided evaluable plasma drug concentrations. | Posted | Mean | Standard Deviation | ng•h/mL | Baseline, 0.75, 2 hours post-treatment |
|
|
|
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. | The treated population included all participants treated with icatibant | Posted | Count of Participants | Participants | From start of study drug administration to follow-up (up to 10 days) |
|
|
|
| Secondary | Number of Participants With Injection Site Reactions Reported as Adverse Event (AE) | Number of participants with injection site reactions (erythema, swelling, cutaneous pain, burning sensation, itching/pruritus, and warm sensation) were reported. | The treated population included all participants treated with icatibant | Posted | Count of Participants | Participants | From start of study drug administration to follow-up (up to 10 days) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests Reported as Adverse Event (AE) | 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. | The treated population included all participants treated with icatibant | Posted | Count of Participants | Participants | From start of study drug administration to follow-up (up to 10 days) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Changes in Vital Signs Reported as Adverse Event (AE) | Vital signs included pulse rate, blood pressure, respiration rate, and temperature. The number of participants with clinically significant changes in vital signs were reported. | The treated population included all participants treated with icatibant | Posted | Count of Participants | Participants | From start of study drug administration to follow-up (up to 10 days) |
|
|
|
| Secondary | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as Adverse Event (AE) | A standard 12-lead ECG was performed. The number of participants who reported clinically significant changes in ECGs were reported. | The treated population included all participants treated with icatibant | Posted | Count of Participants | Participants | From start of study drug administration to follow-up (up to 10 days) |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 3 |
| 8 |
| HEADACHE | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
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.
| D000081207 | Primary Immunodeficiency Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| Title | Measurements |
|---|---|
|
| 8 hours |
|
|
| Abdominal Symptoms: 2 h post dose |
|
| Abdominal Symptoms: 4 h post dose |
|
| Abdominal Symptoms: 8 h post dose |
|
| Laryngeal Symptoms: 2 h post dose |
|
| Laryngeal Symptoms: 4 h post dose |
|
| Laryngeal Symptoms: 8 h post dose |
|