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CompletedNCT01347190Updated Apr 5, 2012

Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic Fibrosis

A Phase 1 interventional study of CR002 Liquid API and Placebo in Cystic Fibrosis, sponsored by CSL Behring. Completed at 11 sites in 4 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-04-05.

Sponsored by CSL Behring · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Study to assess safety and tolerability of a single dose of study-drug administered to Cystic Fibrosis (CF) patients.

02

Conditions studied

  • Cystic Fibrosis

Keywords

  • Cystic Fibrosis
03

In context

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's enrollment of 25 is below the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

CSL Behring is the lead sponsor of 142 studies on the registry; 18 are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 17 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Liquid API

    Biological: CR002 Liquid API

  • Placebo comparator
    Placebo

    Biological: Placebo

Interventions

  • BiologicalCR002 Liquid API

    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.

  • BiologicalPlacebo

    A single nominal dose of Placebo will be inhaled as an aerosol mist produced by an I-neb Adaptive Aerosol Delivery (AAD) System.

06

What researchers measure

Primary outcomes

  1. Frequency of Adverse events

    Time frame: 44 Days (Day -21 to Day 22)

07

Study locations

11 sites
  • Site 11
    Sofia, Bulgaria
  • Site 12
    Varna, Bulgaria
  • Site 30
    Debrecen, Hungary
  • Site 24
    Bialystok, Poland
  • Site 22
    Gdansk, Poland
  • Site 21
    Poznan, Poland
  • Site 20
    Rabka Zdroj, Poland
  • Site 23
    Warszawa, Poland
  • Site 42
    Papworth Hospital, United Kingdom
  • Site 40
    Penarth, United Kingdom
  • Site 41
    Southampton, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01347190
Lead sponsor
CSL Behring
Responsible party
Sponsor
First posted
May 4, 2011
Start date
Apr 2011
Primary completion
Aug 2011
Completion
Aug 2011
Last update
Apr 5, 2012

Study contacts

Program director Clinical R&D
study director · CSL Behring
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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