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Trial record 12 of 22 for:    "Hemosiderosis" | "Iron Chelating Agents"

ENTRUST, a 5 Year Surveillance of Children Aged 2 to <6 Years With Transfusional Iron Overload Treated With Deferasirox

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.
 
ClinicalTrials.gov Identifier: NCT00466063
Recruitment Status : Completed
First Posted : April 27, 2007
Last Update Posted : December 29, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date April 25, 2007
First Posted Date April 27, 2007
Last Update Posted Date December 29, 2015
Study Start Date May 2007
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 17, 2010)
Safety - renal and hepatic function monitoring. [ Time Frame: 5 years ]
Original Primary Outcome Measures
 (submitted: April 25, 2007)
Safety - renal and hepatic function monitoring.
Change History Complete list of historical versions of study NCT00466063 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 17, 2010)
  • Adverse events [ Time Frame: 5 years ]
  • Longitudinal ferritin levels [ Time Frame: 5 years ]
  • Assessment of auditory and ophthalmologic status [ Time Frame: 5 years ]
Original Secondary Outcome Measures
 (submitted: April 25, 2007)
  • Adverse events
  • Longitudinal ferritin levels
  • Assessment of auditory and ophthalmologic status
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ENTRUST, a 5 Year Surveillance of Children Aged 2 to <6 Years With Transfusional Iron Overload Treated With Deferasirox
Official Title A 5 Year Observational Study (Registry) of Children Aged 2 to <6 Years at Enrollment With Transfusional Hemosiderosis Treated With Deferasirox
Brief Summary This registry will evaluate long-term safety and efficacy of deferasirox in children with transfusional iron overload.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 200 unselected children aged from 2 to <6 years at enrolment with chronic iron overload due to repeated blood transfusions. The participating countries were selected on the basis of both a high incidence of young children with thalassemia or other transfusion dependent anemias and on the basis that the drug is approved and 'on the market' in the country selected.
Condition Anemia
Intervention Drug: Deferasirox
Study Groups/Cohorts ICL670
ICL670
Intervention: Drug: Deferasirox
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 26, 2015)
108
Original Enrollment
 (submitted: April 25, 2007)
200
Actual Study Completion Date July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • History of transfusion-dependent anemia.
  • History of iron overload

Exclusion Criteria:

  • Patients with non-transfusional hemosiderosis.

Other protocol-defined inclusion/exclusion criteria may apply.

Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 5 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00466063
Other Study ID Numbers CICL670A2411
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor Novartis Pharmaceuticals
Collaborators Not Provided
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date December 2015