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Study Name: KB001-A in People with CF and Pseudomonas Aeruginosa
Study Type: Interventional
Intervention Category: Anti-Inflammatory
Study Sponsor: Kalobios
Study Phase: 2
Recruitment Status: Recruiting
Study Drug(s): KB001-A
Number of Participants Being Recruited: 180
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
The purpose of this trial is to to evaluate the effect of KB001-A on time-to-need for antibiotic treatment (IV, inhaled, or oral) for worsening of respiratory tract signs and symptoms compared with placebo in people with CF who have chronic Pseudomonas aeruginosa (Pa) lung infection. Study participants will be randomized to receive 5 IV infusions of either study drug or placebo. Sputum specimens of blood, sputum, and urine will be taken during the trial as well as pulmonary lung function testing performed. This trial will last up to 22 weeks.
ELIGIBILITY
Age: 12 Years - 50 Years
FEV1: 40 - 100 Percent Predicted
P. aeruginosa status: Positive
B. cepacia status: Negative
Other Primary Eligibility Requirements:

Received anti-pseudomonal inhaled antibiotics for the equivalent of 8 weeks or greater in the 26 weeks before the Day 0 Visit. Note: Chronic daily anti-pseudomonal inhaled antibiotic regimens are allowed.

Individuals with CF who are older than 50 years may participate if they have been treated with 2 or more courses of antibiotics (IV and/or oral) for respiratory signs and symptoms (CF exacerbation) in the 12 months before the Screening Visit.
Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information:
Trial Specific Link on ClinicalTrials.gov: http://clinicaltrials.gov/show/NCT01695343
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

Secondary Efficacy:

Safety:

Citation:

Pediatr Pulmonol ;DOI 10.1002/ppul.22890

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