A Phase 2 HAE Prophylaxis Study With Recombinant Human C1 Inhibitor
NCT ID: NCT02247739
Last Updated: 2017-12-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
32 participants
INTERVENTIONAL
2014-12-31
2016-09-30
Brief Summary
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To evaluate the efficacy of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of angioedema attacks in patients with HAE
Secondary Objective:
To evaluate the safety and immunogenicity of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of angioedema attacks in patients with HAE
Detailed Description
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This is a multi-center, randomized, double-blind, placebo-controlled, 3-period crossover study of rhC1INH in prophylaxis of angioedema attacks in patients with HAE.
Medical screening (clinical and laboratory parameters) will be performed and patient medical history specific to HAE attacks will be collected to assess eligibility. Each patient will receive three 4 week periods of treatment twice weekly.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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rhC1INH twice weekly
rhC1INH administered twice weekly
Recombinant human C1 inhibitor
rhC1INH once weekly
rhC1INH administered once weekly
Recombinant human C1 inhibitor
Placebo (Saline) twice weekly
Placebo (Saline) administered twice weekly
Placebo
Interventions
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Recombinant human C1 inhibitor
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Age 13 years or older
2. Laboratory confirmed diagnosis of HAE
3. A history of frequent HAE attacks (at least 4 attacks per month across a minimum of 3 consecutive months).
4. Female patients of childbearing potential who are sexually active must be willing to use an acceptable form of contraception.
5. Provided written informed consent (and written assent for minors)
6. Willingness and ability to comply with all protocol procedures
Exclusion Criteria
1. Patients with medical history of allergy to rabbits or rabbit-derived products (including rhC1INH)
2. Diagnosis of acquired angioedema (AAE)
3. Patients who are pregnant, or breastfeeding, or are currently intending to become pregnant
4. Treatment with any investigational drug in the past 30 days
5. Patients with any condition or treatment that, in the opinion of the Investigator, might interfere with the evaluation of study objectives
6. Patients currently treated with angiotensin-converting enzyme (ACE) inhibitors
13 Years
ALL
No
Sponsors
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Pharming Technologies B.V.
INDUSTRY
Responsible Party
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Locations
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University of South Florida Asthma, Allergy and Immunology Clinical Research Unit
Tampa, Florida, United States
University of South Florida, Asthma, Allergy & Immunology Clinical Research Unit
Tampa, Florida, United States
Washington University Division of Allergy and Immunology
St Louis, Missouri, United States
Baker Allergy, Asthma and Dermatology Research Center
Lake Oswego, Oregon, United States
Ottawa Allergy Research Corp
Ottawa, Ontario, Canada
Faculty Hospital by St. Anna Brno, Department of clinical Immunology and Allergology
Brno, , Czechia
Azienda Ospedaliera Universitaria Luigi Sacco Di Milano
Milan, , Italy
PHI University Clinic of Dermatology
Skopje, , North Macedonia
SC Centrul Clinic Mediquest SRL
Sângeorgiu de Mureş, Mureș County, Romania
Clinical Center Serbia
Belgrade, , Serbia
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.
Riedl MA, Grivcheva-Panovska V, Moldovan D, Baker J, Yang WH, Giannetti BM, Reshef A, Andrejevic S, Lockey RF, Hakl R, Kivity S, Harper JR, Relan A, Cicardi M. Recombinant human C1 esterase inhibitor for prophylaxis of hereditary angio-oedema: a phase 2, multicentre, randomised, double-blind, placebo-controlled crossover trial. Lancet. 2017 Sep 30;390(10102):1595-1602. doi: 10.1016/S0140-6736(17)31963-3. Epub 2017 Jul 25.
Other Identifiers
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C1 3201
Identifier Type: -
Identifier Source: org_study_id