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This study is a randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | Subjects received a single dose of 600 mg KVD900. |
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| Part 2 - Sequence 1: 600 mg KVD900, Then Placebo | Experimental | Subjects received a single dose of 600 mg KVD900 to treat the first eligible HAE attack. Following resolution of this attack, subjects received a second single dose of placebo to treat the second eligible HAE attack. |
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| Part 2 - Sequence 2: Placebo, Then 600 mg KVD900 | Experimental | Subjects received a single dose of placebo to treat the first eligible HAE attack. Following resolution of this attack, subjects received a second single dose of 600 mg KVD900 to treat the second eligible HAE attack. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KVD900 | Drug | KVD900 tablet 600 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Conventional Attack Treatment Use Within 12 Hours of Study Drug (Full Analysis Set) | The primary variable for statistical comparison between treatments in Part 2 of the study was time to use of conventional attack treatment (pdC1INH or rhC1INH intravenous [iv] or icatibant) within 12 hours of study drug. Censoring occurs where a subject did not use conventional attack treatment within 12h post-study drug dosing. When an endpoint result was non-calculable (NC) within 12 hours, if the event did occur, the event must have occurred >12 hours following study drug. | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of HAE Attacks That Worsen in Severity by One Level or More on the PGI-S or Require Conventional Attack Treatment Within 12 Hours of Study Drug (Full Analysis Set) | The proportion of participant's HAE attacks to either worsen in attack severity on the PGI-S by one level or more or conventional attack treatment (pdC1INH or rhC1INH intravenous [iv] or icatibant) use are listed with censored observations flagged. Frequencies (n, %) of subjects experiencing a worsening on the PGI-S by one level or more or using conventional attack treatment and the number censored are presented. "Y" Row indicates "participants who experienced a worsening in severity, and the "N" Row indicates participants who did not. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | KalVista Pharmaceuticals, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KalVista Investigative Site | Scottsdale | Arizona | 85251 | United States | ||
| KalVista Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42318595 | Derived | Aygoren-Pursun E, Cohn DM, Agmon-Levin N, Banerji A, Bernstein JA, Busse P, Cancian M, de Castro ED, Farkas H, Grivcheva-Panovska V, Hagin D, Hakl R, Honda D, Kessel A, Kinaciyan T, Ifaad, Kurowski M, Li HH, Lleonart R, Longhurst HJ, Lumry WR, Magerl M, Martinez-Saguer I, Melamed I, Psarros F, Savic S, Soteres DF, Staevska M, Stobiecki M, Wedner HJ, Zanichelli A, Hao J, Patil K, Iverson M, Owiredu-Yeboa S, Smith MD, Yea CM, Audhya PK, Riedl MA, Kiani-Alikhan S, Maurer M. Sebetralstat for on-demand treatment of hereditary angioedema: A pooled analysis of placebo-controlled clinical trials. World Allergy Organ J. 2026 Jun 9;19(7):101401. doi: 10.1016/j.waojou.2026.101401. eCollection 2026 Jul. | |
| 36774155 |
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A total of 68 subjects were entered into the open-label safety, tolerability and PK section (Part 1) and subsequently into Part 2, where all 68 subjects were randomized, with 34 subjects randomized to Sequence 1 (600 mg KVD900; Placebo) and 34 subjects randomized to Sequence 2 (Placebo; 600 mg KVD900).
A total of 84 subjects were enrolled, of which 16 were screen failures. The majority of screen failures were due to inclusion criterion not met.
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| ID | Title | Description |
|---|---|---|
| FG000 | 600 mg KVD900, Then Placebo | Subjects received a single dose of 600 mg KVD900 to treat the first eligible HAE attack. Following resolution of this attack, subjects received a second single dose of placebo to treat the second eligible HAE attack. |
| FG001 | Placebo, Then 600 mg KVD900 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 24, 2020 | Nov 24, 2021 |
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| Placebo | Other | KVD900-matched Placebo Tablet |
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| 12 hours |
| Time to Either Worsening in HAE Attack Severity by One Level or More on the PGI-S or to Conventional Attack Treatment Use Within 12 Hours of Study Drug (Full Analysis Set) | HAE attack severity assessed using the Patient Global Impression of Severity scale (PGI-S). Censoring occurs where a subject did not worsen in severity or use conventional attack treatment (pdC1INH or rhC1INH intravenous [iv] or icatibant) within 12h post-study drug dosing. When an endpoint result was non-calculable (NC) within 12 hours, if the event did occur, the event must have occurred >12 hours following study drug. | 12 hours |
| Time to Symptom Relief Defined as HAE Attack Rated as "A Little Better" or Higher on the PGI-C for Two Consecutive Time Points Within 12 Hours of Study Drug (Full Analysis Set) | Change in HAE attack severity assessed using the Patient Global Impression of Change 7-point transition question (PGI-C). Censoring occurs where an attack rating of "a little better" or higher for two consecutive time points does not occur or conventional attack treatment is used within 12h post-study drug dosing. When an endpoint result was non-calculable (NC) within 12 hours, if the event did occur, the event must have occurred >12 hours following study drug. | 12 hours |
| Time to Symptom Relief Defined as 50% Reduction in Composite VAS Score for Three Consecutive Time Points Within 12 Hours of Study Drug (Full Analysis Set) | The HAE attack symptoms were assessed on a 100 mm visual analogue scale (VAS) ranging from 0 (none) to 100 (very severe). The Composite VAS score is defined as the mean score across all symptoms. Censoring occurs where a ≥50% reduction in Composite VAS Score for three consecutive time points does not occur or conventional attack treatment is used within 12h post-study drug dosing. When an endpoint result was non-calculable (NC) within 12 hours, if the event did occur the event must have occurred >12 hours following study drug. | 12 hours |
| Centennial |
| Colorado |
| 80112 |
| United States |
| KalVista Investigative Site | Chevy Chase | Maryland | 20815 | United States |
| KalVista Investigative Site | Cincinnati | Ohio | 45231 | United States |
| KalVista Investigative Site | Dallas | Texas | 75231 | United States |
| KalVista Investigative Site | Spokane | Washington | 99204 | United States |
| KalVista Investigative Site | Vienna | Austria |
| KalVista Investigative Site | Brno | Czechia |
| KalVista Investigative Site | Hradec Králové | Czechia |
| KalVista Investigative Site | Pilsen | Czechia |
| KalVista Investigative Site | Berlin | Germany |
| KalVista Investigative Site | Frankfurt | Germany |
| KalVista Investigative Site | Mörfelden-Walldorf | Germany |
| KalVista Investigative Site | Budapest | Hungary |
| KalVista Investigative Site | Milan | 1 | Italy |
| KalVista Investigative Site | Milano-2 | Italy |
| KalVista Investigative Site | Padova | Italy |
| KalVista Investigative Site | Amsterdam | Netherlands |
| KalVista Investigative Site | Skopje | North Macedonia |
| KalVista Investigative Site | Krakow | Poland |
| KalVista Investigative Site | Warsaw | Poland |
| KalVista Investigative Site | Camberley | United Kingdom |
| KalVista Investigative Site | Cambridge | United Kingdom |
| KalVista Investigative Site | London | United Kingdom |
| KalVista Investigative Site | Newcastle | United Kingdom |
| Derived |
| Aygoren-Pursun E, Zanichelli A, Cohn DM, Cancian M, Hakl R, Kinaciyan T, Magerl M, Martinez-Saguer I, Stobiecki M, Farkas H, Kiani-Alikhan S, Grivcheva-Panovska V, Bernstein JA, Li HH, Longhurst HJ, Audhya PK, Smith MD, Yea CM, Maetzel A, Lee DK, Feener EP, Gower R, Lumry WR, Banerji A, Riedl MA, Maurer M. An investigational oral plasma kallikrein inhibitor for on-demand treatment of hereditary angioedema: a two-part, randomised, double-blind, placebo-controlled, crossover phase 2 trial. Lancet. 2023 Feb 11;401(10375):458-469. doi: 10.1016/S0140-6736(22)02406-0. |
Subjects received a single dose of placebo to treat the first eligible HAE attack. Following resolution of this attack, subjects received a second single dose of 600 mg KVD900 to treat the second eligible HAE attack. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 600 mg KVD900, Then Placebo | Subjects received a single dose of 600 mg KVD900 to treat the first eligible HAE attack. Following resolution of this attack, subjects received a second single dose of placebo to treat the second eligible HAE attack. |
| BG001 | Placebo, Then 600 mg KVD900 | Subjects received a single dose of placebo to treat the first eligible HAE attack. Following resolution of this attack, subjects received a second single dose of 600 mg KVD900 to treat the second eligible HAE attack. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Height | Mean | Standard Deviation | meters |
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| Weight | Mean | Standard Deviation | kg |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| 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 Conventional Attack Treatment Use Within 12 Hours of Study Drug (Full Analysis Set) | The primary variable for statistical comparison between treatments in Part 2 of the study was time to use of conventional attack treatment (pdC1INH or rhC1INH intravenous [iv] or icatibant) within 12 hours of study drug. Censoring occurs where a subject did not use conventional attack treatment within 12h post-study drug dosing. When an endpoint result was non-calculable (NC) within 12 hours, if the event did occur, the event must have occurred >12 hours following study drug. | A total of 53/68 subjects (77.9%) completed the study. First interquartile values and 95% CI are NA (9.5 to NDA) and 8.0 (3.8 to NA) for the 600 mg KVD900 and Placebo Arm/Groups respectively. Here NA is identical to the footnote. | Posted | Median | 95% Confidence Interval | Time (h) | 12 hours |
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| Secondary | Proportion of HAE Attacks That Worsen in Severity by One Level or More on the PGI-S or Require Conventional Attack Treatment Within 12 Hours of Study Drug (Full Analysis Set) | The proportion of participant's HAE attacks to either worsen in attack severity on the PGI-S by one level or more or conventional attack treatment (pdC1INH or rhC1INH intravenous [iv] or icatibant) use are listed with censored observations flagged. Frequencies (n, %) of subjects experiencing a worsening on the PGI-S by one level or more or using conventional attack treatment and the number censored are presented. "Y" Row indicates "participants who experienced a worsening in severity, and the "N" Row indicates participants who did not. | A total of 53/68 subjects (77.9%) completed the study. | Posted | Count of Participants | Participants | 12 hours |
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| Secondary | Time to Either Worsening in HAE Attack Severity by One Level or More on the PGI-S or to Conventional Attack Treatment Use Within 12 Hours of Study Drug (Full Analysis Set) | HAE attack severity assessed using the Patient Global Impression of Severity scale (PGI-S). Censoring occurs where a subject did not worsen in severity or use conventional attack treatment (pdC1INH or rhC1INH intravenous [iv] or icatibant) within 12h post-study drug dosing. When an endpoint result was non-calculable (NC) within 12 hours, if the event did occur, the event must have occurred >12 hours following study drug. | A total of 53/68 subjects (77.9%) completed the study. First interquartile values and 95% CI are NA (5.9 to NA) and 3.0 (2.0 to 6.0) for the 600 mg KVD900 and Placebo Arm/Groups respectively. Here NA is identical to the footnote. | Posted | Median | 95% Confidence Interval | Time (h) | 12 hours |
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| Secondary | Time to Symptom Relief Defined as HAE Attack Rated as "A Little Better" or Higher on the PGI-C for Two Consecutive Time Points Within 12 Hours of Study Drug (Full Analysis Set) | Change in HAE attack severity assessed using the Patient Global Impression of Change 7-point transition question (PGI-C). Censoring occurs where an attack rating of "a little better" or higher for two consecutive time points does not occur or conventional attack treatment is used within 12h post-study drug dosing. When an endpoint result was non-calculable (NC) within 12 hours, if the event did occur, the event must have occurred >12 hours following study drug. | A total of 53/68 subjects (77.9%) completed the study. First interquartile values and 95% CI are 0.6 (0.6 to 1.5) and 2.0 (0.6 to 4.0) for the 600 mg KVD900 and Placebo Arm/Groups respectively. Here NA is identical to the footnote. | Posted | Median | 95% Confidence Interval | Time (h) | 12 hours |
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| Secondary | Time to Symptom Relief Defined as 50% Reduction in Composite VAS Score for Three Consecutive Time Points Within 12 Hours of Study Drug (Full Analysis Set) | The HAE attack symptoms were assessed on a 100 mm visual analogue scale (VAS) ranging from 0 (none) to 100 (very severe). The Composite VAS score is defined as the mean score across all symptoms. Censoring occurs where a ≥50% reduction in Composite VAS Score for three consecutive time points does not occur or conventional attack treatment is used within 12h post-study drug dosing. When an endpoint result was non-calculable (NC) within 12 hours, if the event did occur the event must have occurred >12 hours following study drug. | A total of 53/68 subjects (77.9%) completed the study. First interquartile values and 95% CI are 2.5 (1.5 to 3.5) and 6.0 (3.0 to NA) for the 600 mg KVD900 and Placebo Arm/Groups respectively. Here NA is identical to the footnote. | Posted | Median | 95% Confidence Interval | Time (h) | 12 hours |
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Adverse events were collected over the maximum duration of randomized subject participation from screening until final visit (up to 19 weeks).
Safety was evaluated for Parts 1 and 2 by the following:
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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 | Part 1: 600 mg KVD900 | Subjects received a single dose of 600 mg KVD900. | 0 | 68 | 0 | 68 | 7 | 68 |
| EG001 | Part 2: 600 mg KVD900 | Subjects received a single dose of 600 mg KVD900 to treat eligible HAE attack. | 0 | 58 | 0 | 58 | 8 | 58 |
| EG002 | Part 2: Placebo | Subjects received a single dose of placebo to treat eligible HAE attack. | 0 | 55 | 0 | 55 | 5 | 55 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Anal incontinence | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Medical device site rash | General disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Clinical | KalVista Pharmaceuticals Ltd. | 1 (857) 999-0075 | clinical@kalvista.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 18, 2021 | Nov 24, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| ID | Term |
|---|---|
| D000799 | Angioedema |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000081208 | Hereditary Complement Deficiency Diseases |
| 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 |
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| ID | Term |
|---|---|
| C000726128 | sebetralstat |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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In Sequence 1, subjects received a single dose of 600 mg KVD900 to treat the first eligible HAE attack. Following resolution of this attack, subjects received a second single dose of placebo to treat the second eligible HAE attack.
In Sequence 2, subjects received a single dose of placebo to treat the first eligible HAE attack. Following resolution of this attack, subjects received a second single dose of 600 mg KVD900 to treat the second eligible HAE attack.
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In Sequence 1, subjects received a single dose of 600 mg KVD900 to treat the first eligible HAE attack. Following resolution of this attack, subjects received a second single dose of placebo to treat the second eligible HAE attack.
In Sequence 2, subjects received a single dose of placebo to treat the first eligible HAE attack. Following resolution of this attack, subjects received a second single dose of 600 mg KVD900 to treat the second eligible HAE attack.
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