We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT01090323
First Posted: March 19, 2010
Last Update Posted: June 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
Results First Submitted: December 21, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Sickle Cell Disease
Intervention: Drug: ICL670

  Participant Flow
  Hide 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
No text entered.

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
  Hide 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
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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
  Hide 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.


  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.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300



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 ( Registry Identifier: EudraCT )
First Submitted: March 15, 2010
First Posted: March 19, 2010
Results First Submitted: December 21, 2010
Results First Posted: January 20, 2011
Last Update Posted: June 6, 2011



To Top