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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 February 2015 |
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Main ID: |
NCT01347190 |
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Date of registration:
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03/05/2011 |
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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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Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic Fibrosis
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Scientific title:
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A Double Blind, Randomized, Placebo Controlled, Single Dose, Phase I Study of the Safety and Tolerability of Alpha1 Proteinase Inhibitor (Human) Inhalation Solution (CR002) in Subjects With Cystic Fibrosis |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01347190 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Bulgaria
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Hungary
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Poland
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United Kingdom
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Contacts
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Name:
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Program director Clinical R&D |
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Address:
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Telephone:
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Email:
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Affiliation:
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CSL Behring |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Have a confirmed diagnosis of CF: one or more clinical findings consistent with CF
and at least one of the following:
1. Sweat chloride = 60 mEq/L by quantitative pilocarpine iontophoresis test OR
2. A genotype with two identifiable mutations consistent with CF (?F508 homozygous
or two alleles known to cause a class I, II, or III mutation)
- Have an FEV1 =30% of predicted normal as defined by age, gender, and height
Exclusion Criteria:
- Oxygen saturation <90%
- Changed in treatment regimen within 2 weeks prior to screening
- Antibiotics regimen change < 4 weeks before screening
- Persistent colonization with Burkholderia cepacia
- Serum IgA < 50% of lower level of normal
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Biological: CR002 Liquid API
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Biological: Placebo
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Primary Outcome(s)
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Frequency of Adverse events
[Time Frame: 44 Days (Day -21 to Day 22)]
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Secondary ID(s)
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CR002_1004
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2010-022671-60
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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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