The Relationship of Defeverscence and Itraconazole Plasma Level Study in Immunocompromised Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01021683
First received: November 25, 2009
Last updated: July 24, 2013
Last verified: July 2013
Results First Received: April 15, 2013  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Hematologic Neoplasms
Neutropenia
Fever
Intervention: Drug: Itraconazole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Itraconazole Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.

Participant Flow:   Overall Study
    Itraconazole  
STARTED     203  
COMPLETED     132  
NOT COMPLETED     71  
Lack of Efficacy                 12  
Recovery of neutrophil count                 51  
unspecified                 8  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline characteristics were reported only for intent-to-treat (ITT) population which included 150 participants.

Reporting Groups
  Description
Itraconazole Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.

Baseline Measures
    Itraconazole  
Number of Participants  
[units: participants]
  150  
Age  
[units: Years]
Mean ± Standard Deviation
  52.2  ± 15.0  
Gender  
[units: Participants]
 
Female     65  
Male     85  



  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving Plasma Level of Itraconazole at 1000 Nanogram Per Milliliter (ng/mL) or Higher After Administration of Study Treatment   [ Time Frame: Day 5 ]

2.  Secondary:   Percentage of Participants With Deferevescence After Administration of Study Treatment   [ Time Frame: Day 0 up to Day 14 ]

3.  Secondary:   Mean Time to Defervescence in Participants Who Received the Study Treatment   [ Time Frame: Day 0 up to Day 14 ]

4.  Secondary:   Duration of Neutropenia   [ Time Frame: Day 0 up to Day 14 ]

5.  Secondary:   Absolute Neutrophil Count (ANC)   [ Time Frame: Baseline (Day 0) ]

6.  Secondary:   Percentage of Participants With Defervescence by Plasma Level of Itraconazole   [ Time Frame: Day 5 ]

7.  Secondary:   Plasma Concentration of Itraconazole by Overall Success Rate (OSR) in Participants Who Received the Study Treatment   [ Time Frame: Day 5 ]

8.  Secondary:   Percentage of Participants With Baseline Fungal Infection   [ Time Frame: Baseline (Day 0) ]

9.  Secondary:   Plasma Concentration of Itraconazole by Breakthrough Fungal Infection   [ Time Frame: Day 5 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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.


Results Point of Contact:  
Name/Title: Clinical Research Associate
Organization: Clinical Research Team, Medical Affairs, Medical Dept. Janssen Korea
phone: +82-2-2094-4879


No publications provided


Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01021683     History of Changes
Other Study ID Numbers: CR016597, ITR-KOR-5085, ITRFUN4049
Study First Received: November 25, 2009
Results First Received: April 15, 2013
Last Updated: July 24, 2013
Health Authority: Korea: Food and Drug Administration