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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
KaloBios Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01695343
First received: September 25, 2012
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
Biological: KB001-A
Drug: Placebo Comparator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by KaloBios Pharmaceuticals:

Primary Outcome Measures:
  • To evaluate the effect of KB001-A on time-to-need for antibiotic (ABX) treatment for worsening of respiratory tract signs and symptoms. [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
    Time-to-need for ABX treatment will be the length of time between study material dosing and administration of ABX as needed for worsening respiratory conditions.


Secondary Outcome Measures:
  • Safety and tolerability of KB001-A [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]
    Safety and tolerability will be measured by Adverse Events (AEs) and laboratory assessments


Estimated Enrollment: 180
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: KB001-A
Placebo Comparator: Placebo Comparator
Placebo administered up to 5x intravenously
Drug: Placebo Comparator

  Eligibility

Ages Eligible for Study:   12 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01695343

  Show 67 Study Locations
Sponsors and Collaborators
KaloBios Pharmaceuticals
Investigators
Study Chair: Nestor A. Molfino, MD., MSc KaloBios Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: KaloBios Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01695343     History of Changes
Other Study ID Numbers: KB001A-05
Study First Received: September 25, 2012
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by KaloBios Pharmaceuticals:
Cystic Fibrosis
Pseudomonas aeruginosa (Pa)
CF

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014