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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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19 April 2022 |
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Main ID: |
NCT03636347 |
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Date of registration:
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20/06/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD With Alvelestat (MPH966) or Placebo.
ASTRAEUS |
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Scientific title:
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A Phase 2, Proof-of-concept, Multicentre, Double-blind, Randomised, Dose-ascending, Sequential Group, Placebo-controlled Study to Evaluate the Mechanistic Effect, Safety, and Tolerability of 12 Weeks Twice Daily Oral Administration of Alvelestat (MPH966) in Participants With Alpha-1 Antitrypsin Deficiency. |
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Date of first enrolment:
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October 29, 2018 |
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Target sample size:
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99 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03636347 |
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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: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Belgium
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Canada
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Denmark
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Poland
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Spain
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Sweden
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United Kingdom
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United States
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Contacts
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Name:
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Robert Stockley, Prof. |
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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 of Birmingham |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with a confirmed diagnosis of alpha-1-anti-trypsin deficiency and a PiZZ,
null or other rare geno/phenotype and serum anti-alpha1 antitrypsin levels of less
than 11uM
- FEV1 =20% predicted
- Computerised tomography (CT) scan evidence of emphysema
- Non-smokers
Exclusion Criteria:
- Primary diagnosis of bronchiectasis
- An ongoing acute exacerbation of the underlying lung disease
- Underlying liver disease or abnormal liver function tests
- Previous augmentation therapy within 6 months of dosing
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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COPD
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Alpha 1-Antitrypsin Deficiency
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Emphysema
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Intervention(s)
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Drug: Placebo Oral Tablet
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Drug: Alvelestat oral tablet - dose 2
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Drug: Alvelestat oral tablet - dose 1
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Primary Outcome(s)
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Change from baseline on blood biomarkers of neutrophil elastase activity compared to baseline and placebo
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Change from baseline on other blood biomarkers of neutrophil elastase activity
[Time Frame: 12 weeks]
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Secondary ID(s)
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2018-001309-95
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MPH966-2-01
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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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