Clinical trial NCT01695343: Study to Evaluate the Effect of KB001-A on Time-to-Need for Antibiotic Treatment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Pseudomonas aeruginosa (Pa)
CF
Lead sponsor: Humanigen, Inc.
Sponsor class: INDUSTRY
First posted: 2012-09-27
Enrollment: 182
Sex: ALL
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the effect of KB001-A on time-to-need for antibiotic (ABX) treatment for worsening of respiratory tract signs and symptoms.
timeFrame: 16 Weeks
Secondary outcomes:
measure: Safety and tolerability of KB001-A
timeFrame: 16 Weeks
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Long Beach
country: United States
state: California
city: Oakland
country: United States
state: California
city: Orange
country: United States
state: California
city: Stanford
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Gainesville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Glenview
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Portland
country: United States
state: Maine
city: Boston
country: United States
state: Massachusetts
city: Worchester
country: United States
state: Massachusetts
city: Detriot
country: United States
state: Michigan
city: Grand Rapids
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Hanover
country: United States
state: New Hampshire
city: Manchester
country: United States
state: New Hampshire
city: Albuquerque
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
city: Hawthorne
country: United States
state: New York
city: New Hyde Park
country: United States
state: New York
city: New York
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Knoxville
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Colchester
country: United States
state: Vermont
city: Richmond
country: United States
state: Virginia
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: New Lambton
country: Australia
state: New South Wales
city: Parkville
country: Australia
state: Victoria
city: Nedlands
country: Australia
state: Western Australia
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Petah-Tikva
country: Israel
city: Tel Hashomer
country: Israel
city: Dunedin
country: New Zealand
city: Hamilton
country: New Zealand
Study officials:
affiliation: KaloBios Pharmaceuticals, Inc.
name: Nestor A. Molfino, MD., MSc
role: STUDY_CHAIR
References: