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Study to Evaluate the Effect of KB001-A on Time-to-Need for Antibiotic Treatment
Recruiting
I'm InterestedTrial ID: NCT01695343
Purpose
The purpose of this study is to confirm and extend the Phase 1-2 KB001 findings of an airway
anti-inflammatory effect in CF individuals with chronic Pseudomonas aeruginosa (Pa) airway
infection. It is hypothesized that steady-state levels of KB001-A in CF subjects with airway
Pa infection will be safe and well-tolerated, and will increase the time-to-need for
antibiotic treatment (IV, inhaled, or oral) for worsening of respiratory tract signs and
symptoms compared with placebo.
Official Title
A Phase 2, Randomized, Double-blind, Placebo-controlled, Repeat-dose Study of KB001-A in Subjects With Cystic Fibrosis Infected With Pseudomonas Aeruginosa
Eligibility
Inclusion Criteria:
- Individuals with CF who are older than 50 years of age may participate if treated with
2 or more courses of antibiotics (IV and/or oral) for respiratory sign and symptoms
(CF exacerbation) in the 12 months before the Screening Visit
- Confirmed diagnosis of CF
- At least 2 respiratory tract cultures in the previous 12 months, with Pa present. The
most recent positive Pa culture must be within 12 weeks before the Screening Visit (or
obtain a positive culture at screening)
- FEV1 % levels within acceptable ranges (per the study protocol)
- Received inhaled ABX for equivalent of 8 weeks or greater in the 26 weeks before the
Day 0 Visit
Exclusion Criteria:
- Treatment with antibiotics for acute illness within the 4 weeks before the Day 0 Visit
- Use of systemic corticosteroids within the 4 weeks before the Day 0 Visit
- Any change in regimen of CF maintenance therapies within the 4 weeks before the Day 0
Visit
- History of sputum cultures positive for B. cepacia complex in the 2 years before the
Screening Visit
- History of organ transplantation
- Current smoker (tobacco, marijuana, or any other material). Use of smokeless
inhalers/vaporizers for these materials is also prohibited
- History of drug addiction or alcohol abuse in the 12 months before the Screening Visit
- History of hepatic disease (clinical cirrhosis or portal hypertension), renal
dysfunction
- Breast-feeding or pregnancy as evidenced by a positive blood pregnancy test
- Receiving any investigational drug in the 16 weeks (or 5 half lives) before the Day 0
Visit, whichever is longer
Intervention(s):
drug: Placebo Comparator
biological: KB001-A
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Carlos Milla
650) 723-8325, (650) 736-9824