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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01695343




Registration number
NCT01695343
Ethics application status
Date submitted
25/09/2012
Date registered
27/09/2012
Date last updated
14/01/2015

Titles & IDs
Public title
Study to Evaluate the Effect of KB001-A on Time-to-Need for Antibiotic Treatment
Scientific title
A Phase 2, Randomized, Double-blind, Placebo-controlled, Repeat-dose Study of KB001-A in Subjects With Cystic Fibrosis Infected With Pseudomonas Aeruginosa
Secondary ID [1] 0 0
KB001A-05
Universal Trial Number (UTN)
Trial acronym
KB001-A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Cystic fibrosis
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: KB001-A - KB001-A administered up to 5x intravenously (IV) at 10 mg/kg up to a maximum dose of 800 mg per dose.

Placebo comparator: Placebo Comparator - Placebo administered up to 5x intravenously
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the effect of KB001-A on time-to-need for antibiotic (ABX) treatment for worsening of respiratory tract signs and symptoms.
Timepoint [1] 0 0
16 Weeks
Secondary outcome [1] 0 0
Safety and tolerability of KB001-A
Timepoint [1] 0 0
16 Weeks

Eligibility
Key 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
Minimum age
12 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
182
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
- New Lambton
Recruitment hospital [2] 0 0
- Parkville
Recruitment hospital [3] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
2305 - New Lambton
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
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Arkansas
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United States of America
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California
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Colorado
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Florida
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Georgia
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Idaho
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Illinois
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Indiana
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Iowa
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Kentucky
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Maine
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Massachusetts
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Michigan
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Minnesota
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Missouri
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New Hampshire
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New Mexico
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New York
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Ohio
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Oklahoma
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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United States of America
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Vermont
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United States of America
State/province [28] 0 0
Virginia
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United States of America
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Wisconsin
Country [30] 0 0
Israel
State/province [30] 0 0
Haifa
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Israel
State/province [31] 0 0
Jerusalem
Country [32] 0 0
Israel
State/province [32] 0 0
Petah-Tikva
Country [33] 0 0
Israel
State/province [33] 0 0
Tel Hashomer
Country [34] 0 0
New Zealand
State/province [34] 0 0
Dunedin
Country [35] 0 0
New Zealand
State/province [35] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Humanigen, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01695343
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nestor A. Molfino, MD., MSc
Address 0 0
KaloBios Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01695343