Study to Evaluate the Effect of KB001-A on Time-to-Need for Antibiotic Treatment

Completed · Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT01695343

Run by

Humanigen, Inc.

People needed

182

Starts

2012-12-01

Expected to finish

2014-12-01

Last updated by the study team

2015-01-14

Who can join

Age: 12 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Long Beach, California, United States
• Study site — Oakland, California, United States
• Study site — Orange, California, United States
• Study site — Stanford, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Gainesville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Glenview, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Lexington, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Portland, Maine, United States
• Study site — Boston, Massachusetts, United States
• Study site — Worchester, Massachusetts, United States
• Study site — Detriot, Michigan, United States
• Study site — Grand Rapids, Michigan, United States
• Study site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.