Safety and Efficacy of Deferasirox (ICL670) in Patients With Iron Overload Resulting From Hereditary Hemochromatosis

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00395629

First received: November 1, 2006

Last updated: May 24, 2011

Last verified: May 2011

History of Changes

Results First Received: December 6, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Iron Overload Hereditary Hemochromatosis
Intervention:	Drug: Deferasirox (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
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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
Deferasirox (ICL670) 5 mg/kg/Day	Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
Deferasirox (ICL670) 10 mg/kg/Day	Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
Deferasirox (ICL670) 15 mg/kg/Day	Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.

Participant Flow for 2 periods

Period 1: Core Study

	Deferasirox (ICL670) 5 mg/kg/Day	Deferasirox (ICL670) 10 mg/kg/Day	Deferasirox (ICL670) 15 mg/kg/Day
STARTED	11	15	23
COMPLETED	10	11	16
NOT COMPLETED	1	4	7
Adverse Event	0	3	4
Abnormal laboratory value(s)	0	0	1
Protocol Violation	1	0	0
Withdrawal by Subject	0	1	1
Lost to Follow-up	0	0	1

Period 2: Extension Study

	Deferasirox (ICL670) 5 mg/kg/Day	Deferasirox (ICL670) 10 mg/kg/Day	Deferasirox (ICL670) 15 mg/kg/Day
STARTED	9	6	11
COMPLETED	9	6	8
NOT COMPLETED	0	0	3
Adverse Event	0	0	2
Administrative problems	0	0	1

Baseline Characteristics

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Reporting Groups

	Description
Deferasirox (ICL670) 5 mg/kg/Day	Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
Deferasirox (ICL670) 10 mg/kg/Day	Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
Deferasirox (ICL670) 15 mg/kg/Day	Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
Total	Total of all reporting groups

Baseline Measures

	Deferasirox (ICL670) 5 mg/kg/Day	Deferasirox (ICL670) 10 mg/kg/Day	Deferasirox (ICL670) 15 mg/kg/Day	Total
Number of Participants [units: participants]	11	15	23	49
Age ^[1] [units: years] Mean ± Standard Deviation
Core Study	55.8 ± 12.78	47.8 ± 10.26	49.8 ± 16.41	50.6 ± 14.04
Extension Study (n=9,6,11,26)	55.7 ± 14.23	44.8 ± 10.61	50.1 ± 15.88	50.8 ± 14.34
Gender, Customized [units: participants]
Female_Core Study	2	4	10	16
Male_Core Study	9	11	13	33
Gender, Customized [units: participants]
Female_Extension Study	1	1	3	5
Male_Extension Study	8	5	8	21
Core Participants not enrolled in the Extension	2	9	12	23

[1]	The n values in the Extension Study Category are the number of participants in each Arm/Group. The last n value= 26 is the Total number of participants.

Outcome Measures

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1. Primary:

Absolute Change of Serum Ferritin From Baseline to the End of Extension, by Dose Cohort (Extension Per-protocol Population) [ Time Frame: 0 to 48 weeks ]

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2. Secondary:

Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population) [ Time Frame: 4, 8, 12, 16, 20, and 24 weeks ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

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
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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:	NCT00395629 History of Changes
Other Study ID Numbers:	CICL670A2202, EudraCT no. 2006-002102-57
Study First Received:	November 1, 2006
Results First Received:	December 6, 2010
Last Updated:	May 24, 2011
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Australia: Department of Health and Ageing Therapeutic Goods Administration Germany: Federal Institute for Drugs and Medical Devices France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Italy: Ministry of Health

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