Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa
NCT ID: NCT00638365
Last Updated: 2014-06-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
27 participants
INTERVENTIONAL
2008-03-31
2009-04-30
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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1
KB001, a monoclonal antibody
KB001
Single-dose, 3mg/kg or 10mg/kg dose administered intravenously
2
Placebo
Placebo
Placebo single-dose administered intravenously
Interventions
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KB001
Single-dose, 3mg/kg or 10mg/kg dose administered intravenously
Placebo
Placebo single-dose administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of CF based on the following criteria:
Positive sweat chloride greater than 60mEq/liter, and/or a genotype with 2 identifiable mutations consistent with CF, and one or more clinical features consistent with the CF phenotype
* Age \>/= 18 years of age with the potential for age 12 \>/=
* Screening Pa sputum culture
* FEV1% predicted \>/= 40 (based on Wang's equations for Males aged 12-17 and females 12-15 years, and Hankinson's equations for all other patients)
Exclusion Criteria
* Use of systemic corticosteroids or antibiotics within 4 weeks prior to day 0, or cyclic inhaled antibiotics within 14 days prior to day 0.
* History of positive B. cepacia complex, organ transplantation, hepatic disease or venal dysfunction
* Current cigarette smoker, history of drug addiction or alcohol abuse
* Use of investigational medication or participation in an investigational study within 4 weeks prior to day 0
* Women who are pregnant or breastfeeding and patients and/or partner unwilling to use an effective form of barrier contraception throughout the study
12 Years
ALL
No
Sponsors
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Humanigen, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Carlos Milla, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Nestor A. Molfino, MD, MSc
Role: STUDY_DIRECTOR
Humanigen, Inc.
Locations
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University of Alabama
Birmingham, Alabama, United States
Lucille Packard Children's Hospital at Stanford
Stanford, California, United States
University of Colorado
Aurora, Colorado, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Minnesota
Minneapolis, Minnesota, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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References
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Milla CE, Chmiel JF, Accurso FJ, VanDevanter DR, Konstan MW, Yarranton G, Geller DE; KB001 Study Group. Anti-PcrV antibody in cystic fibrosis: a novel approach targeting Pseudomonas aeruginosa airway infection. Pediatr Pulmonol. 2014 Jul;49(7):650-8. doi: 10.1002/ppul.22890. Epub 2013 Sep 9.
Other Identifiers
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KB001-03
Identifier Type: -
Identifier Source: org_study_id
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