Evaluation of the Safety, Tolerability, Pharmacokinetics (PK) and Effects on Liver Iron Concentration of ICL670 Relative to Deferoxamine(DFO).

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT01090323
First received: March 15, 2010
Last updated: May 3, 2011
Last verified: May 2011
Results First Received: December 21, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Sickle Cell Disease
Intervention: Drug: ICL670

  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
ICL670 Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
Crossover Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.

Participant Flow:   Overall Study
    ICL670     Crossover  
STARTED     132     53  
COMPLETED     43     19  
NOT COMPLETED     89     34  
Adverse Event                 12                 2  
Abnormal Lab Values                 3                 1  
Abnormal Test Procedure Results                 2                 0  
Unsatisfactory therapeutic effect                 4                 2  
Condition no longer requires drug                 5                 4  
Protocol Violation                 2                 1  
Withdrew consent                 33                 11  
Lost to Follow-up                 11                 6  
Administrative problems                 6                 4  
Death                 1                 2  
Stopped end of core                 7                 0  
Stopped end of extension 1#                 3                 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
ICL670 Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
Crossover Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
Total Total of all reporting groups

Baseline Measures
    ICL670     Crossover     Total  
Number of Participants  
[units: participants]
  132     53     185  
Age, Customized  
[units: participants]
     
<12 years     33     14     47  
12 - <16 years     32     11     43  
16 - <65 years     67     28     95  
Gender  
[units: participants]
     
Female     80     31     111  
Male     52     22     74  
Region of Enrollment  
[units: participants]
     
France     10     2     12  
United States     110     46     156  
Canada     0     1     1  
United Kingdom     5     1     6  
Italy     7     3     10  



  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events After Start of ICL670   [ Time Frame: 0 - 60 months ]

2.  Secondary:   Change in Serum Ferritin From Start of ICL670 to End of Study   [ Time Frame: 0 - 60 months ]


  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: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01090323     History of Changes
Obsolete Identifiers: NCT00171197
Other Study ID Numbers: CICL670A0109E1, EudraCT no. 2004-000597-31
Study First Received: March 15, 2010
Results First Received: December 21, 2010
Last Updated: May 3, 2011
Health Authority: United States: Food and Drug Administration
Italy: Ministry of Health
Canada: Health Canada
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
United Kingdom: Medicines and Healthcare Products Regulatory Agency