Safety and Efficacy of Ferriprox™ (Deferiprone) Oral Solution in Iron Overloaded Pediatric Patients

This study has been completed.
Sponsor:
Information provided by:
ApoPharma
ClinicalTrials.gov Identifier:
NCT00529152
First received: September 12, 2007
Last updated: August 25, 2009
Last verified: August 2009
Results First Received: June 26, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Iron Overload
Intervention: Drug: Deferiprone

  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
No text entered.

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
Ferriprox Oral Solution All subjects were administered Ferriprox Oral Solution three times daily for a total daily dose of either 50, 75 or 100 mg/kg/day. Subjects were initiated at a dose of 50 mg/kg/day, but this dose could be increased after two weeks of therapy depending on the subjects' individual needs.

Participant Flow:   Overall Study
    Ferriprox Oral Solution  
STARTED     100  
COMPLETED     95  
NOT COMPLETED     5  
Adverse Event                 2  
Withdrawal by Subject                 2  
Lost to Follow-up                 1  



  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.
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Reporting Groups
  Description
Ferriprox Oral Solution All subjects were administered Ferriprox Oral Solution three times daily for a total daily dose of either 50, 75 or 100 mg/kg/day. Subjects were initiated at a dose of 50 mg/kg/day, but this dose could be increased after two weeks of therapy depending on the subjects' individual needs.

Baseline Measures
    Ferriprox Oral Solution  
Number of Participants  
[units: participants]
  100  
Age  
[units: years]
Mean ± Standard Deviation
  5.1  ± 2.4  
Gender  
[units: participants]
 
Female     46  
Male     54  
Region of Enrollment  
[units: participants]
 
Egypt     76  
Malaysia     11  
Indonesia     13  
serum ferritin [1]
[units: ug/L]
Mean ± Standard Deviation
  2531.7  ± 1463.0  
[1] serum ferritin measures the amount of iron in the blood



  Outcome Measures
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1.  Primary:   Occurrence of Adverse Events   [ Time Frame: 24 Weeks ]

2.  Secondary:   Change in Serum Ferritin Concentration From Baseline.   [ Time Frame: Baseline and 24 weeks ]


  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: Dian Shaw, Manager Clinical Research
Organization: ApoPharma
phone: 416-401-7283
e-mail: dshaw@apotex.com


No publications provided by ApoPharma

Publications automatically indexed to this study:

Responsible Party: Dian Shaw, ApoPharma Inc.
ClinicalTrials.gov Identifier: NCT00529152     History of Changes
Other Study ID Numbers: LA30-0307
Study First Received: September 12, 2007
Results First Received: June 26, 2009
Last Updated: August 25, 2009
Health Authority: Egypt: Ministry of Health and Population