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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02870972 |
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Date of registration:
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10/08/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema
APeX-1 |
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Scientific title:
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A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel-group Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BCX7353 as a Preventative Treatment to Reduce the Frequency of Attacks in Subjects With Hereditary Angioedema |
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Date of first enrolment:
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August 2016 |
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Target sample size:
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75 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02870972 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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Austria
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Canada
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Denmark
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Germany
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Hungary
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Italy
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Macedonia, The Former Yugoslav Republic of
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Spain
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Switzerland
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United Kingdom
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Contacts
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Name:
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Emel Aygören-Pürsün, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Frankfurt Goethe University |
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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
- A clinical diagnosis of HAE type I or II
- Documented HAE attacks within a defined calendar period
- Access to acute attack medications
- Sexually active women of child-bearing potential and sexually active men must utilize
effective contraception
Key Exclusion Criteria:
- Women who are pregnant or breast-feeding
- Any clinical condition or medical history that would interfere with the subject's
safety or ability to participate in the study
- Use of C1INH, androgens or tranexamic acid for prophylaxis of HAE attacks
- History of or current alcohol or drug abuse
- Infection with hepatitis B, hepatitis C or HIV
- Participation in any other investigational drug study currently or within the last 30
days
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hereditary Angioedema (HAE)
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Intervention(s)
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Drug: BCX7353
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Drug: Placebo
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Primary Outcome(s)
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Number of confirmed HAE attacks
[Time Frame: 28 days]
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Secondary Outcome(s)
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Quality of Life, as measured by the Depression, Anxiety, Stress Scales (DASS) questionnaire
[Time Frame: 28 days]
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Plasma concentrations of BCX7353 at steady state
[Time Frame: 28 days]
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Quality of Life, as measured by the Angioedema Quality of Life Questionnaire
[Time Frame: 28 days]
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Incidence and severity of adverse events and laboratory abnormalities
[Time Frame: 28 days]
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Secondary ID(s)
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BCX7353-203
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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