Study to Evaluate the Effect of KB001-A on Time-to-Need for Antibiotic Treatment
NCT ID: NCT01695343
Last Updated: 2015-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
182 participants
INTERVENTIONAL
2012-12-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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KB001-A
KB001-A administered up to 5x intravenously (IV) at 10 mg/kg up to a maximum dose of 800 mg per dose.
KB001-A
Placebo Comparator
Placebo administered up to 5x intravenously
Placebo Comparator
Interventions
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KB001-A
Placebo Comparator
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
50 Years
ALL
No
Sponsors
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Humanigen, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nestor A. Molfino, MD., MSc
Role: STUDY_CHAIR
KaloBios Pharmaceuticals, Inc.
Locations
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Mobile, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Long Beach, California, United States
Oakland, California, United States
Orange, California, United States
Stanford, California, United States
Aurora, Colorado, United States
Gainesville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Boise, Idaho, United States
Glenview, Illinois, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Portland, Maine, United States
Boston, Massachusetts, United States
Worchester, Massachusetts, United States
Detriot, Michigan, United States
Grand Rapids, Michigan, United States
Minneapolis, Minnesota, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Hanover, New Hampshire, United States
Manchester, New Hampshire, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Hawthorne, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Colchester, Vermont, United States
Richmond, Virginia, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
New Lambton, New South Wales, Australia
Parkville, Victoria, Australia
Nedlands, Western Australia, Australia
Haifa, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Tel Litwinsky, , Israel
Dunedin, , New Zealand
Hamilton, , New Zealand
Countries
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Other Identifiers
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KB001A-05
Identifier Type: -
Identifier Source: org_study_id
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