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A 5 Year Observational Study (Registry) of Children Aged 2 to <6 Years at Enrollment With Transfusional Hemosiderosis Treated With Deferasirox


Phase 4
2 Years
5 Years
Open (Enrolling)
Both
Anemia

Thank you

Trial Information

A 5 Year Observational Study (Registry) of Children Aged 2 to <6 Years at Enrollment With Transfusional Hemosiderosis Treated With Deferasirox


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Safety - renal and hepatic function monitoring.

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CICL670A2411

NCT ID:

NCT00466063

Start Date:

May 2007

Completion Date:

Related Keywords:

  • Anemia
  • Iron overload
  • children
  • deferasirox
  • Transfusion-dependent anemia
  • Anemia
  • Iron Overload

Name

Location

Stanford University Medical CenterStanford, California  94305-5408
Hackensack University Medical CenterHackensack, New Jersey  07601
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital of Orange CountyOrange, California  92668
University of South Alabama Medical CenterMobile, Alabama  36604
Schneider Children's HospitalNew Hyde Park, New York  11042
Children's Hospital of the King's DaughtersNorfolk, Virginia  23507
Akron Children's HospitalAkron, Ohio  44308-1062
St. Joseph's Children's Hospital of TampaTampa, Florida  33677-4227
Children's Hospital BostonBoston, Massachusetts  02115
Texas Children's HospitalHouston, Texas  
Children's Memorial HospitalChicago, Illinois  60614
Cook's Children's Medical CenterFort Worth, Texas  76104
Children's Hospital OaklandOakland, California  94609
Children's Medical CenterDayton, Ohio  45404
East Carolina UniversityGreenville, North Carolina  27858
MD Anderson Cancer Center - OrlandoOrlando, Florida  32806
St. Joseph's Children's HospitalPaterson, New Jersey  07503
The Brooklyn Hospital CenterBrooklyn, New York  11201
SUNY - Upstate Medical UniversitySyracuse, New York  13210
Oklahoma State University Health Sciences CenterOklahoma City, Oklahoma  73104
Penn State University / Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
St. Jude Children's Research Hospital MemphisMemphis, Tennessee  38105-2794