Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1 Esterase Inhibitor for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema
NCT ID: NCT02584959
Last Updated: 2021-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
75 participants
INTERVENTIONAL
2015-11-01
2017-07-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Experimental/Placebo
Subjects will be randomized to receive C1 Esterase Inhibitor in the 1st Treatment period and then switch to Placebo in the 2nd treatment period.
C1 esterase inhibitor [human] liquid
C1 Esterase Inhibitor \[Human\] Liquid administered Subcutaneously as specified on specified days
Placebo
Placebo
Placebo/Experimental
Subjects will be randomized to receive a placebo treatment in the 1st Treatment period and then switch to receive C1 Esterase Inhibitor in the 2nd treatment period.
C1 esterase inhibitor [human] liquid
C1 Esterase Inhibitor \[Human\] Liquid administered Subcutaneously as specified on specified days
Placebo
Placebo
Experimental/ Experimental
Subjects will be randomized and receive C1 Esterase Inhibitor in both 1st as well as the 2nd treatment period
C1 esterase inhibitor [human] liquid
C1 Esterase Inhibitor \[Human\] Liquid administered Subcutaneously as specified on specified days
Interventions
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C1 esterase inhibitor [human] liquid
C1 Esterase Inhibitor \[Human\] Liquid administered Subcutaneously as specified on specified days
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
12 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Medical Research of Arizona
Scottsdale, Arizona, United States
AIRE Medical of Los Angeles
Santa Monica, California, United States
Bay Area Allergy
Walnut Creek, California, United States
IMMUNOe Research Centers
Centennial, Colorado, United States
Asthma and Allergy Associates PC
Colorado Springs, Colorado, United States
Atlanta Allergy and Asthma Clinic
Marietta, Georgia, United States
Institute For Asthma and Allergy
Chevy Chase, Maryland, United States
Washington University
St Louis, Missouri, United States
Allergy Asthma and Immunology
Fair Lawn, New Jersey, United States
Allergy Treatment Center of New Jersey
Iselin, New Jersey, United States
Clinical Research of Charlotte
Charlotte, North Carolina, United States
Bernstein Clinical Research Center Inc
Cincinnati, Ohio, United States
Clinical Research Solutions
Middleburg Heights, Ohio, United States
Allergy Clinic of Tulsa
Tulsa, Oklahoma, United States
AARA Research Center
Dallas, Texas, United States
Premier Clinical Research
Spokane, Washington, United States
McMaster University Medical Center
Hamilton, Ontario, Canada
Ottawa Allergy Research Corporation
Ottawa, Ontario, Canada
Hämophilie Zentrum Rhein Main GmbH
Mörfelden-Walldorf, , Germany
Semmelweis Egyetem
Budapest, , Hungary
Chaim Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
MediQuest Clinical Research Center
Târgu Mureş, , Romania
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Countries
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References
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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.
Lumry WR, Martinez-Saguer I, Yang WH, Bernstein JA, Jacobs J, Moldovan D, Riedl MA, Johnston DT, Li HH, Tang Y, Schranz J, Lu P, Vardi M, Farkas H; SAHARA study group. Fixed-Dose Subcutaneous C1-Inhibitor Liquid for Prophylactic Treatment of C1-INH-HAE: SAHARA Randomized Study. J Allergy Clin Immunol Pract. 2019 May-Jun;7(5):1610-1618.e4. doi: 10.1016/j.jaip.2019.01.021. Epub 2019 Jan 23.
Provided Documents
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Document Type: Study Protocol: Protocol
Document Type: Study Protocol: Amendment1
Document Type: Study Protocol: Amendment2
Document Type: Study Protocol: Amendment3
Document Type: Study Protocol: Amendment4
Document Type: Statistical Analysis Plan
Other Identifiers
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SHP616-300
Identifier Type: -
Identifier Source: org_study_id
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