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A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579)

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ClinicalTrials.gov Identifier: NCT01716234
Recruitment Status : Terminated (Study was terminated early (10 July 2015) based on preliminary analysis of pharmacokinetic data.)
First Posted : October 29, 2012
Results First Posted : April 15, 2016
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Fungal Infections
Interventions: Drug: Posaconazole 12 mg/kg/day BID
Drug: Posaconazole 18 mg/kg/day BID
Drug: Posaconazole 18 mg/kg/day TID
Drug: Posaconazole 12 mg/kg/day TID

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 160 participants were screened, 142 were randomized / enrolled, and 136 were treated. An arm planned for participants aged 3 months to <2 years to receive posaconazole 18 mg/kg/day TID was never initiated.

Reporting Groups
  Description
POS 12 BID 2 to <7 Years Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
POS 12 BID 7 to <18 Years Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
POS 18 BID 2 to <7 Years Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
POS 18 BID 7 to <18 Years Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
POS 18 TID 2 to <7 Years Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
POS 18 TID 7 to <18 Years Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
POS 12 TID 3 Months to <2 Years Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.

Participant Flow:   Overall Study
    POS 12 BID 2 to <7 Years   POS 12 BID 7 to <18 Years   POS 18 BID 2 to <7 Years   POS 18 BID 7 to <18 Years   POS 18 TID 2 to <7 Years   POS 18 TID 7 to <18 Years   POS 12 TID 3 Months to <2 Years
STARTED   24   22   20   28   15   32   1 
Treated   22   21   19   28   15   30   1 
COMPLETED   14   12   15   16   10   18   1 
NOT COMPLETED   10   10   5   12   5   14   0 
Protocol Violation                0                0                0                1                1                1                0 
Lack of Efficacy                0                0                0                1                0                0                0 
Did not meet protocol eligibility                0                0                1                0                0                4                0 
Adverse Event                7                10                2                8                3                6                0 
Withdrawal by Subject                3                0                2                2                1                3                0 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
POS 12 BID 2 to <7 Years Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
POS 12 BID 7 to <18 Years Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
POS 18 BID 2 to <7 Years Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
POS 18 BID 7 to <18 Years Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
POS 18 TID 2 to <7 Years Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
POS 18 TID 7 to <18 Years Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
POS 12 TID 3 Months to <2 Years Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
Total Total of all reporting groups

Baseline Measures
   POS 12 BID 2 to <7 Years   POS 12 BID 7 to <18 Years   POS 18 BID 2 to <7 Years   POS 18 BID 7 to <18 Years   POS 18 TID 2 to <7 Years   POS 18 TID 7 to <18 Years   POS 12 TID 3 Months to <2 Years   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   22   20   28   15   32   1   142 
Age 
[Units: Years]
Mean (Standard Deviation)
 4.0  (1.3)   11.9  (3.5)   4.4  (1.5)   12.2  (3.2)   4.1  (1.3)   13.1  (3.0)   0.9  (0)   8.9  (4.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
               
Female      10  41.7%      12  54.5%      8  40.0%      9  32.1%      6  40.0%      14  43.8%      0   0.0%      59  41.5% 
Male      14  58.3%      10  45.5%      12  60.0%      19  67.9%      9  60.0%      18  56.3%      1 100.0%      83  58.5% 


  Outcome Measures

1.  Primary:   Average Concentration of Posaconazole (Cavg) on Day 1 (Single Dose)   [ Time Frame: Up to 12 hours after the first dose (BID dose groups) or up to 8 hours after the first dose (TID dose (TID dose groups) ]

2.  Primary:   Average Concentration of Posaconazole (Cavg) on Day 7 (Steady State)   [ Time Frame: Up to 12 hours after the first dose on Day 7 (BID dose groups) or up to 8 hours after the first dose on Day 7 (TID dose ]

3.  Secondary:   Number of Participants With an Adverse Event   [ Time Frame: Up to Day 58 ]

4.  Secondary:   Number of Participants With an Adverse Event Leading to Study Drug Discontinuation   [ Time Frame: Up to Day 28 ]


  Serious Adverse Events


  Other Adverse Events


  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
Only 1 participant was enrolled in the POS 12 TID 3 months to <2 years group, limiting conclusions that may be drawn for pharmacokinetics or safety.


  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.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01716234     History of Changes
Other Study ID Numbers: P03579
2007-004645-15 ( EudraCT Number )
MK-5592-032 ( Other Identifier: Merck )
First Submitted: October 25, 2012
First Posted: October 29, 2012
Results First Submitted: March 15, 2016
Results First Posted: April 15, 2016
Last Update Posted: May 9, 2017