A Randomized, Open-label, Multi-center, Phase II Study to Evaluate the Safety and Efficacy of Deferasirox (ICL670) 20 mg/kg/Day Relative to Subcutaneous Deferoxamine in Sickle Cell Disease Patients With Iron Overload From Repeated Blood Transfusions
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The Number of Participants With Adverse Events (AEs) in the First 24 Weeks of Treatment
The number of participants with Adverse Events (AEs) overall and according to Medical Dictionary for Regulatory Activities (MedDRA) preferred term greater than or equal to 5% participants in any group by treatment in the first 24 weeks.
24 Weeks
Yes
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CICL670A2201
NCT00110617
May 2005
April 2008
Name | Location |
---|---|
Howard University Hospital | Washington, District of Columbia 20060 |
University of Michigan | Ann Arbor, Michigan 48109-0624 |
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Loma Linda University Medical Center | Loma Linda, California 92354 |
New York Methodist Hospital | Brooklyn, New York 11215-3609 |
Children's National Medical Center | Washington, District of Columbia 20010-2970 |
Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
University of South Alabama Medical Center | Mobile, Alabama 36604 |
Miami Children's Hospital | Miami, Florida 33155-4069 |
Weill Medical College of Cornell University | New York, New York 10021 |
University of Illinois at Chicago | Chicago, Illinois 60612 |
SUNY Downstate Medical Center | Brooklyn, New York 11203 |
Emory University School of Medicine | Atlanta, Georgia 30322 |
Columbia University | New York, New York 10032-3784 |
Children's Hospital Boston | Boston, Massachusetts 02115 |
Medical College of Virginia | Richmond, Virginia 23298-0341 |
Children's Memorial Hospital | Chicago, Illinois 60614 |
Santee Hematology/Oncology | Sumter, South Carolina 29150 |
Virginia Commonwealth University | Richmond, Virginia |
Karmanos Cancer Institute | Detroit, Michigan 48201 |
Children's Hospital Oakland | Oakland, California 94609 |
Drexel University College of Medicine | Philadelphia, Pennsylvania 19129 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
Tampa Children's Hospital at St Joseph's | Tampa, Florida 33607 |
Tulane University Sickle Cell Center | New Orleans, Louisiana 70112 |
Sickle Cell Center, Montefiore Hospital | Bronx, New York 10467 |
Children's Hospital Medical Center | Cincinnati, Ohio 45229 |
Liberty Hematology Oncology Center | Columbia, South Carolina 29203 |
Palmetto Health Clinical Trials | Columbia, South Carolina 29203 |
Texas Children's Hospital/Baylor College of Medicine | Houston, Texas 77030 |
Scott and White Memorial Hospital & Clinics | Temple, Texas 76508 |
Children's Hospital of the King's Daughter | Norfolk, Virginia 23507 |
Hillman Cancer Center | Pittsburg, Pennsylvania 15232 |
University of South Alabama | Mobile, Alabama 36693 |
University of Alabama Pediatric Hematology/Oncology | Birmingham, Alabama 35233 |
University of Alabama Medical center | Birmingham, Alabama 35294 |
Center for Cancer and Blood Disorders | Washington, District of Columbia 20010-2970 |
Tampa Children's Hospital at St. Joseph's | Tampa, Florida 33607-6387 |
H. Lee Muffit Cancer Center and Research Institute/James A. Haley Veterans Hospital | Tampa, Florida 33612 |
Children's Healthcare of Atlanta at Scottish Rite | Atlanta, Georgia 30342 |
Adult Sickle Cell Clinic | Augusta, Georgia 30912-3128 |
Backus Children's Hospital | Savannah, Georgia 31403 |
Pediatric Sickle Cell Program/James Whitcomb Riley Hospital for Children | Indianapolis, Indiana 46202 |
St. Jude Children's Hospital Affiliate | Baton Rouge, Louisiana 70808 |
Children's Hospital | New Orleans, Louisiana 70118 |
LSU Health Sciences Center/Carroll W. Feist Professor of Cancer Research | Shreveport, Louisiana 71130 |
Children's Hospital | Boston, Massachusetts 02115 |
Brigham and Woman's Hospital/Harvard Medical School | Boston, Massachusetts 02115 |
Carolinas Medical Transplant Center | Charlotte, North Carolina 28232 |
The University of Oklahoma | Oklahoma City, Oklahoma 73104 |
Jefferson University | Philadelphia, Pennsylvania 19107 |
Pennsylvania Oncology/Hematology | Philadelphia, Pennsylvania 19106 |
St Jude's Children's Research Hospital | Memphis, Tennessee 38105-2794 |
St. Jude's Children Research Hospital | Memphis, Tennessee 38105 |
Cooks Children's Hospital | Fort Worth, Texas 76104-2724 |