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The study objective was to describe the pharmacokinetics (PK) of one or two doses of C1 esterase inhibitor (C1INH-nf) in hereditary angioedema (HAE) subjects who were not experiencing an HAE attack.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Dose | Experimental | 1,000 Units (U) of C1INH-nf administered intravenously (IV). |
|
| First Dose Followed by Second Dose | Experimental | 1,000 U of C1INH-nf administered IV, followed by a second 1,000 U dose 60 minutes later. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C1 esterase inhibitor [human] (C1INH-nf) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK will be analyzed by means of incremental recovery, in vivo half-life, area under the curve, clearance, and mean residence time. | 1 week | |
| C1 inhibitor (functional and antigenic) and C4 antigen serum levels will be measured at a United States Clinical Laboratory Improvement Amendments-certified laboratory and the research division of Sanquin Blood Supply Foundation. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of adverse events. | 3 months | |
| Change in clinical laboratory safety parameters from pre- to post-infusion. | 3 months | |
| Change in vital signs from pre- to post-infusion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | San Diego | California | 92093-0732 | United States | ||
| Allergy and Asthma Clinical Research, Inc. |
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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 |
|---|---|
| D050718 | Complement C1 Inhibitor Protein |
| ID | Term |
|---|---|
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D003174 | Complement C1 Inactivator Proteins |
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| 30 minutes (Single Dose), 90 minutes (First Dose Followed by Second Dose) |
| Walnut Creek |
| California |
| 94598 |
| United States |
| Family Allergy and Asthma Center | Atlanta | Georgia | 30342 | United States |
| Institute for Asthma and Allergy | Wheaton | Maryland | 20902 | United States |
| Penn State University | Hershey | Pennsylvania | 17033 | United States |
| AARA Research Center | Dallas | Texas | 75231 | United States |
| 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 |
| D015843 |
| Serpins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003169 | Complement Inactivator Proteins |
| D003165 | Complement System Proteins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |