Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic Fibrosis
Information source: CSL Behring
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis
Intervention: CR002 Liquid API (Biological); Placebo (Biological)
Phase: Phase 1
Status: Completed
Sponsored by: CSL Behring Official(s) and/or principal investigator(s): Program director Clinical R&D, Study Director, Affiliation: CSL Behring
Summary
Study to assess safety and tolerability of a single dose of study-drug administered to
Cystic Fibrosis (CF) patients.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Frequency of Adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
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
Additional Information
Starting date: April 2011
Last updated: April 3, 2012
|