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The purpose of this study is to determine whether BCX4161 given as a daily oral prophylactic treatment is safe and effective in reducing the number of acute attacks in patients with hereditary angioedema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCX4161 | Active Comparator | 400 mg TID for 28 days |
|
| Placebo | Placebo Comparator | TID for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCX4161 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of acute angioedema attacks | Over 28 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events and laboratory abnormalities | Over 28 days of treatment | |
| Number of attack free days | Over 28 days of treatment | |
| Angioedema Quality of Life scores |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcus Maurer, MD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Marcus Maurer | Berlin | Germany | ||||
| Dr Emel Aygoren-Pursun |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36326435 | Derived | Beard N, Frese M, Smertina E, Mere P, Katelaris C, Mills K. Interventions for the long-term prevention of hereditary angioedema attacks. Cochrane Database Syst Rev. 2022 Nov 3;11(11):CD013403. doi: 10.1002/14651858.CD013403.pub2. |
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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 |
|---|---|
| C000722673 | avoralstat |
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|
| Over 28 days of treatment |
| Angioedema activity scores | Over 28 days of treatment |
| Frankfurt |
| Germany |
| Dr Petra Staubach | Mainz | Germany |
| Dr Inmaculada Martinez-Saguer | Mörfelden-Walldorf | Germany |
| Dr Murat Bas | München | Germany |
| Dr Hilary Longhurst | London | United Kingdom |
| 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 |