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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 Center Stanford, California  94305-5408
Hackensack University Medical Center Hackensack, New Jersey  07601
Children's Hospital Los Angeles Los Angeles, California  90027-0700
Children's Hospital of Orange County Orange, California  92668
University of South Alabama Medical Center Mobile, Alabama  36604
Schneider Children's Hospital New Hyde Park, New York  11042
Children's Hospital of the King's Daughters Norfolk, Virginia  23507
Akron Children's Hospital Akron, Ohio  44308-1062
St. Joseph's Children's Hospital of Tampa Tampa, Florida  33677-4227
Children's Hospital Boston Boston, Massachusetts  02115
Texas Children's Hospital Houston, Texas  
Children's Memorial Hospital Chicago, Illinois  60614
Cook's Children's Medical Center Fort Worth, Texas  76104
Children's Hospital Oakland Oakland, California  94609
Children's Medical Center Dayton, Ohio  45404
East Carolina University Greenville, North Carolina  27858
MD Anderson Cancer Center - Orlando Orlando, Florida  32806
St. Joseph's Children's Hospital Paterson, New Jersey  07503
The Brooklyn Hospital Center Brooklyn, New York  11201
SUNY - Upstate Medical University Syracuse, New York  13210
Oklahoma State University Health Sciences Center Oklahoma City, Oklahoma  73104
Penn State University / Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
St. Jude Children's Research Hospital Memphis Memphis, Tennessee  38105-2794