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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005013-36 | EudraCT Number |
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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
The aim of the study is to assess what happens to C1-esterase inhibitor that is administered under the skin of subjects with hereditary angioedema. Three different dosing regimens of C1-esterase inhibitor will be assessed. Each subject will be assigned to receive 2 of the 3 dosing regimens, each for 4 weeks. The activity and concentration of C1-esterase inhibitor in the blood will be measured during each 4-week period. The study will also examine how well C1-esterase inhibitor administered under the skin is tolerated by the subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low, then medium, C1-esterase inhibitor dose | Experimental |
| |
| Medium, then low, C1-esterase inhibitor dose | Experimental |
| |
| Medium, then high, C1-esterase inhibitor dose | Experimental |
| |
| Low, then high, C1-esterase inhibitor dose | Experimental |
| |
| High, then low, C1-esterase inhibitor dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C1-esterase inhibitor - single intravenous dose | Biological | A single intravenous dose of C1-esterase inhibitor (Berinert) at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor. |
| Measure | Description | Time Frame |
|---|---|---|
| Modeled C1-esterase Inhibitor Functional Activity Trough Level | Mean trough C1-esterase inhibitor functional activity of the low, medium and high subcutaneous dose regimens, based on modeling and simulation | at the fourth week of each dosing regimen |
| Measure | Description | Time Frame |
|---|---|---|
| As-observed C1-esterase Inhibitor Functional Activity Trough Level | Mean trough C1-esterase inhibitor functional activity of the low, medium and high subcutaneous dose regimens | during the last week of 4-week dose regimen |
| C1-esterase Inhibitor Concentration Trough Level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Program Director | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site | Atlanta | Georgia | 30342 | United States | ||
| Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26016741 | Result | Zuraw BL, Cicardi M, Longhurst HJ, Bernstein JA, Li HH, Magerl M, Martinez-Saguer I, Rehman SM, Staubach P, Feuersenger H, Parasrampuria R, Sidhu J, Edelman J, Craig T. Phase II study results of a replacement therapy for hereditary angioedema with subcutaneous C1-inhibitor concentrate. Allergy. 2015 Oct;70(10):1319-28. doi: 10.1111/all.12658. Epub 2015 Aug 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low, Then Medium, CSL830 Dose | C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1-esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous low dose (CSL830): A low dose of C1-esterase inhibitor (1500 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous medium dose (CSL830): A medium dose of C1-esterase inhibitor (3000 IU) will be administered subcutaneously twice a week for four weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Dosing Period 1 |
|
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| High, then medium, C1-esterase inhibitor dose | Experimental |
|
| C1-esterase inhibitor - subcutaneous low dose | Biological | A low dose of C1-esterase inhibitor will be administered subcutaneously twice a week for four weeks. |
|
| C1-esterase inhibitor - subcutaneous medium dose | Biological | A medium dose of C1-esterase inhibitor will be administered subcutaneously twice a week for four weeks. |
|
| C1-esterase inhibitor - subcutaneous high dose | Biological | A high dose of C1-esterase inhibitor will administered subcutaneously twice a week for four weeks. |
|
Mean trough C1-esterase inhibitor concentration of the low, medium and high subcutaneous dose regimens |
| during the last week of 4-week dose regimen |
| C4 Concentration Trough Level | Mean trough C4 concentration of the low, medium and high subcutaneous dose regimens | during the last week of 4-week dose regimen |
| Change From Baseline in C1-esterase Inhibitor Functional Activity | Mean change from baseline of C1-esterase inhibitor functional activity of the low, medium and high subcutaneous dose regimens | Baseline and during the last week of 4-week dose regimen |
| Change From Baseline in C1-esterase Inhibitor Concentration | Mean change from baseline of C1-esterase inhibitor concentration of the low, medium and high subcutaneous dose regimens | Baseline and during the last week of 4-week dose regimen |
| Change From Baseline in C4 Concentration | Mean change from baseline of C4 concentration of the low, medium and high subcutaneous dose regimens | Baseline and during the last week of 4-week dose regimen |
| Chevy Chase |
| Maryland |
| 20815 |
| United States |
| Study Site | Cincinnati | Ohio | 45231 | United States |
| Study Site | Toledo | Ohio | 43617 | United States |
| Study Site | Hershey | Pennsylvania | 19108 | United States |
| Study Site | Berlin | 10117 | Germany |
| Study Site | Frankfurt | 60596 | Germany |
| Study Site | Mainz | 55101 | Germany |
| FG001 | Medium, Then Low, CSL830 Dose | C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1-esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous medium dose (CSL830): A medium dose of C1-esterase inhibitor (3000 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous low dose (CSL830): A low dose of C1-esterase inhibitor (1500 IU) will be administered subcutaneously twice a week for four weeks. |
| FG002 | Medium, Then High, CSL830 Dose | C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1-esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous medium dose (CSL830): A medium dose of C1-esterase inhibitor (3000 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous high dose (CSL830): A high dose of C1-esterase inhibitor (6000 IU) will administered subcutaneously twice a week for four weeks. |
| FG003 | Low, Then High, CSL830 Dose | C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1-esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous low dose (CSL830): A low dose of C1-esterase inhibitor (1500 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous high dose (CSL830): A high dose of C1-esterase inhibitor (6000 IU) will administered subcutaneously twice a week for four weeks. |
| FG004 | High, Then Low, CSL830 Dose | C1-esterase inhibitor - single intravenous dose:(Berinert): A single intravenous dose of C1-esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous high dose (CSL830): A high dose of C1-esterase inhibitor (6000 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous low dose (CSL830): A low dose of C1-esterase inhibitor (1500 IU) will administered subcutaneously twice a week for four weeks. |
| FG005 | High, Then Medium, CSL830 Dose | C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1-esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous high dose (CSL830): A high dose of C1-esterase inhibitor (6000 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous medium dose (CSL830): A medium dose of C1-esterase inhibitor (3000 IU) will be administered subcutaneously twice a week for four weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Dosing Period 2 |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Low, Then Medium, CSL830 Dose | C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1- esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous low dose (CSL830): A low dose of C1- esterase inhibitor (1500 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous medium dose (CSL830): A medium dose of C1-esterase inhibitor (3000 IU) will be administered subcutaneously twice a week for four weeks. |
| BG001 | Medium, Then Low, CSL830 Dose | C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1- esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous medium dose (CSL830): A medium dose of C1-esterase inhibitor (3000 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous low dose (CSL830): A low dose of C1- esterase inhibitor (1500 IU) will be administered subcutaneously twice a week for four weeks. |
| BG002 | Medium, Then High, CSL830 Dose | C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1- esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous medium dose (CSL830): A medium dose of C1-esterase inhibitor (3000 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous high dose (CSL830): A high dose of C1-esterase inhibitor (6000 IU) will administered subcutaneously twice a week for four weeks. |
| BG003 | Low, Then High, CSL830 Dose | C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1- esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous low dose (CSL830): A low dose of C1- esterase inhibitor (1500 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous high dose (CSL830): A high dose of C1-esterase inhibitor (6000 IU) will administered subcutaneously twice a week for four weeks. |
| BG004 | High, Then Low, CSL830 Dose | C1-esterase inhibitor - single intravenous dose:(Berinert): A single intravenous dose of C1- esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous high dose (CSL830): A high dose of C1-esterase inhibitor (6000 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous low dose (CSL830): A low dose of C1- esterase inhibitor (1500 IU) will administered subcutaneously twice a week for four weeks. |
| BG005 | High, Then Medium, CSL830 Dose | C1-esterase inhibitor - single intravenous dose(Berinert): A single intravenous dose of C1- esterase inhibitor at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor (CSL830). C1-esterase inhibitor - subcutaneous high dose (CSL830): A high dose of C1-esterase inhibitor (6000 IU) will be administered subcutaneously twice a week for four weeks, then C1-esterase inhibitor - subcutaneous medium dose (CSL830): A medium dose of C1-esterase inhibitor (3000 IU) will be administered subcutaneously twice a week for four weeks. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Modeled C1-esterase Inhibitor Functional Activity Trough Level | Mean trough C1-esterase inhibitor functional activity of the low, medium and high subcutaneous dose regimens, based on modeling and simulation | Complete Analysis Set (CAS) - Subjects received at least 1 dose (complete or incomplete) of the dosing regimen of CSL830 and provided at least 1 C1-INH functional activity measurement during the dosing regimen (prior to the use of any prohibited concomitant therapy or prohibited change in dosage of a concomitant therapy) | Posted | Mean | Standard Deviation | percent functional activity | at the fourth week of each dosing regimen |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | As-observed C1-esterase Inhibitor Functional Activity Trough Level | Mean trough C1-esterase inhibitor functional activity of the low, medium and high subcutaneous dose regimens | As-observed analysis set - subset of the full analysis set (FAS). FAS consisted of all enrolled subjects (all subjects who gave informed consent). | Posted | Mean | Standard Deviation | percent functional activity | during the last week of 4-week dose regimen |
|
| ||||||||||||||||||||||||||||||||
| Secondary | C1-esterase Inhibitor Concentration Trough Level | Mean trough C1-esterase inhibitor concentration of the low, medium and high subcutaneous dose regimens | As-observed analysis set | Posted | Mean | Standard Deviation | mg/mL | during the last week of 4-week dose regimen |
|
| ||||||||||||||||||||||||||||||||
| Secondary | C4 Concentration Trough Level | Mean trough C4 concentration of the low, medium and high subcutaneous dose regimens | As-observed analysis set | Posted | Mean | Standard Deviation | mg/dL | during the last week of 4-week dose regimen |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in C1-esterase Inhibitor Functional Activity | Mean change from baseline of C1-esterase inhibitor functional activity of the low, medium and high subcutaneous dose regimens | As-observed analysis set | Posted | Mean | Standard Deviation | percent functional activity | Baseline and during the last week of 4-week dose regimen |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in C1-esterase Inhibitor Concentration | Mean change from baseline of C1-esterase inhibitor concentration of the low, medium and high subcutaneous dose regimens | As-observed analysis set | Posted | Mean | Standard Deviation | mg/mL | Baseline and during the last week of 4-week dose regimen |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in C4 Concentration | Mean change from baseline of C4 concentration of the low, medium and high subcutaneous dose regimens | As-observed analysis set | Posted | Mean | Standard Deviation | mg/dL | Baseline and during the last week of 4-week dose regimen |
|
|
Up to 14 weeks per subject
The safety set consisted of all enrolled subjects who received at least 1 dose (complete or incomplete) of study drug (Berinert or CSL830). Subjects were included in the safety set for a dosing regimen only if they received at least 1 dose of that dosing regimen (e.g., a subject who discontinued prior to taking the dosing period 2 dosing regimen was not included in the safety set for that dosing regimen).
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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 | Berinert | C1-esterase inhibitor - single intravenous dose: A single intravenous dose of C1-esterase inhibitor (Berinert) at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor. | 0 | 18 | 1 | 18 | 4 | 18 |
| EG001 | CSL830 (Low Dose) | A low dose of C1-esterase inhibitor (1500 IU) administered subcutaneously twice a week for four weeks | 0 | 12 | 0 | 12 | 10 | 12 |
| EG002 | CSL830 (Medium Dose) | A medium dose of C1-esterase inhibitor (3000 IU) administered subcutaneously twice a week for four weeks | 0 | 12 | 0 | 12 | 8 | 12 |
| EG003 | CSL830 (High Dose) | A high dose of C1-esterase inhibitor (6000 IU) administered subcutaneously twice a week for four weeks | 0 | 12 | 1 | 12 | 9 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Syncope | Nervous system disorders | MedDRA version 14.1 | Systematic Assessment |
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| Hypovolemic shock | Vascular disorders | MedDRA version 14.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA version 14.1 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA version 14.1 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA version 14.1 | Systematic Assessment |
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| Injection site haematoma | General disorders | MedDRA version 14.1 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA version 14.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA version 14.1 | Systematic Assessment |
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| Induration | General disorders | MedDRA version 14.1 | Systematic Assessment |
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| Injection site paraesthesia | General disorders | MedDRA version 14.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 14.1 | Systematic Assessment |
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| Swelling | General disorders | MedDRA version 14.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 14.1 | Systematic Assessment |
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| Acute sinusitis | Infections and infestations | MedDRA version 14.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 14.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 14.1 | Systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA version 14.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 14.1 | Systematic Assessment |
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| Hypotonia | Nervous system disorders | MedDRA version 14.1 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA version 14.1 | Systematic Assessment |
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| Neuritis | Nervous system disorders | MedDRA version 14.1 | Systematic Assessment |
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| Hereditary angioedema | Congenital, familial and genetic disorders | MedDRA version 14.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 14.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 14.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA version 14.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 14.1 | Systematic Assessment |
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| Aphthous stomatitis | Gastrointestinal disorders | MedDRA version 14.1 | Systematic Assessment |
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| Diarrrhoea | Gastrointestinal disorders | MedDRA version 14.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA version 14.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 14.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 14.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 14.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 14.1 | Systematic Assessment |
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| Myositis | Musculoskeletal and connective tissue disorders | MedDRA version 14.1 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA version 14.1 | Systematic Assessment |
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| Metrorrhagia | Reproductive system and breast disorders | MedDRA version 14.1 | Systematic Assessment |
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| Ovarian Cyst ruptured | Reproductive system and breast disorders | MedDRA version 14.1 | Systematic Assessment |
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| Uterine spasm | Reproductive system and breast disorders | MedDRA version 14.1 | Systematic Assessment |
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| Vaginal discharge | Reproductive system and breast disorders | MedDRA version 14.1 | Systematic Assessment |
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| Mouth injury | Injury, poisoning and procedural complications | MedDRA version 14.1 | Systematic Assessment |
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| Muscle rupture | Injury, poisoning and procedural complications | MedDRA version 14.1 | Systematic Assessment |
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| Urine analysis abnormal | Investigations | MedDRA version 14.1 | Systematic Assessment |
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| Urine leukocyte esterase positive | Investigations | MedDRA version 14.1 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA version 14.1 | Systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA version 14.1 | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA version 14.1 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA version 14.1 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA version 14.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA version 14.1 | Systematic Assessment |
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| Renal pain | Renal and urinary disorders | MedDRA version 14.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 14.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA version 14.1 | Systematic Assessment |
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CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | CSL Behring | 610-878-4000 | clinicaltrials@cslbehring.com |
| ID | Term |
|---|---|
| D056829 | Hereditary Angioedema Types I and II |
| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| D000799 | Angioedema |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
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