Back to resultsSafety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CR002 Liquid API
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic Fibrosis
Eligibility Criteria
Inclusion Criteria:
Have a confirmed diagnosis of CF: one or more clinical findings consistent with CF and at least one of the following:
- Sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR
- 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
Sites / Locations
- Site 11
- Site 12
- Site 30
- Site 24
- Site 22
- Site 21
- Site 20
- Site 23
- Site 42
- Site 40
- Site 41
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Liquid API
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Frequency of Adverse events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01347190
Brief Title
Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic Fibrosis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Behring
4. Oversight
5. Study Description
Brief Summary
Study to assess safety and tolerability of a single dose of study-drug administered to Cystic Fibrosis (CF) patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liquid API
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
CR002 Liquid API
Intervention Description
A single nominal dose of CR002 (three different dose groups) will be inhaled as an aerosol mist produced by an I-neb Adaptive Aerosol Delivery (AAD) System.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
A single nominal dose of Placebo will be inhaled as an aerosol mist produced by an I-neb Adaptive Aerosol Delivery (AAD) System.
Primary Outcome Measure Information:
Title
Frequency of Adverse events
Time Frame
44 Days (Day -21 to Day 22)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a confirmed diagnosis of CF: one or more clinical findings consistent with CF and at least one of the following:
Sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Program director Clinical R&D
Organizational Affiliation
CSL Behring
Official's Role
Study Director
Facility Information:
Facility Name
Site 11
City
Sofia
Country
Bulgaria
Facility Name
Site 12
City
Varna
Country
Bulgaria
Facility Name
Site 30
City
Debrecen
Country
Hungary
Facility Name
Site 24
City
Bialystok
Country
Poland
Facility Name
Site 22
City
Gdansk
Country
Poland
Facility Name
Site 21
City
Poznan
Country
Poland
Facility Name
Site 20
City
Rabka Zdroj
Country
Poland
Facility Name
Site 23
City
Warszawa
Country
Poland
Facility Name
Site 42
City
Papworth Hospital
Country
United Kingdom
Facility Name
Site 40
City
Penarth
Country
United Kingdom
Facility Name
Site 41
City
Southampton
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic Fibrosis
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