Text Size

Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
KaloBios Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00638365
First received: March 12, 2008
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
Results First Received: July 12, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cystic Fibrosis
Interventions: Biological: KB001
Other: Placebo

  Participant Flow
  Show Participant Flow


  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Placebo No text entered.
KB001, 3 mg/kg No text entered.
KB001, 10 mg/kg No text entered.
Total Total of all reporting groups

Baseline Measures
    Placebo     KB001, 3 mg/kg     KB001, 10 mg/kg     Total  
Number of Participants  
[units: participants]
 		  9     10     8     27  
Age  
[units: participants]
 		       
<=18 years     0     2     0     2  
Between 18 and 65 years     9     8     8     25  
>=65 years     0     0     0     0  
Gender  
[units: participants]
 		       
Female     2     5     2     9  
Male     7     5     6     18  
Region of Enrollment  
[units: participants]
 		       
United States     9     10     8     27  



  Outcome Measures

1.  Primary:   The Safety and Tolerability of a Single-dose of KB001.   [ Time Frame: Day 28 ]
  Show Outcome Measure 1


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Nestor A. Molfino, MD., MSc
Organization: KaloBios Pharmaceuticals, Inc.
phone: 650-243-3103
e-mail: nmolfino@kalobios.com


No publications provided


Responsible Party: KaloBios Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00638365     History of Changes
Other Study ID Numbers: KB001-03
Study First Received: March 12, 2008
Results First Received: July 12, 2011
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board