NCT01090323 - Evaluation of the Safety, Tolerability, Pharmacokinetics (PK) and Effects on Liver Iron Concentration of ICL670 Relative to Deferoxamine(DFO). | Biotech Hunter

Enrollment

185

Participants

Timeline

Start Date

July 31, 2004

Primary Completion Date

July 31, 2009

Conditions

Sickle Cell Disease

Interventions

DRUG

ICL670

Daily doses of ICL670 were taken orally 30 minutes before breakfast. The doses range from 5-40 mg/kg and were determined based on the patient's trend in serum ferritin over time during the core study (0109) and on the frequency of blood transfusions the patient received. The treatment duration was up to 4 years.

Trial Locations (39)

10021

New York Presbyterian Hospital, New York

10467

Montefiore Medical Center, The Bronx

11215

New York Methodist Hospital, Brooklyn

15213

Children's Hospital of Pittsburgh, Pittsburgh

17033

Milton S. Hershey Medical Center, Hershey

19104

Yasin, Philadelphia

20059

Howard University Hospital, Washington D.C.

23507

Children's Hospital of the King's Daughters, Norfolk

27157

Wake Forest University Health Sciences, Winston-Salem

29150

Santee Hematology/Oncology, Sumter

29203

Palmetto Health Richland, Columbia

30303

Grady Hospital, Georgia Comprehensive Sickle Cell Center, Atlanta

30912

Medical College of Georgia, Augusta

33607

St Joseph Children's Hospital of Tampa, Tampa

36604

University of South Alabama College of Medicine, Mobile

38105

St. Jude's Children Research Hospital, Memphis

45229

Children's Hospital Medical Center, Cincinnati

45267

University of Cincinnati, Cincinnati

48201

Karmanos Cancer Institute, Detroit

60612

University of Illinois at Chicago, Chicago

60614

Children's Memorial Hospital, Chicago

70112

Tulane University Medical Center, New Orleans

71130

LSUHSC Dept of Pediatrics, Shreveport

76508

Scott & White Memorial Hospital, Temple

77030

Texas Children's Hospital, Houston

The Methodist Hospital, Houston

80262

University of Colorado Health Science Center, Denver

90027

Children's Hospital Los Angeles, Los Angeles

90609

Children's Hospital & Research Center at Oakland, Oakland

92354

Loma Linda University Medical Center, Loma Linda

02118

Children's Hospital Boston, Boston

Unknown

Novartis Investigative Site, Toronto

Novartis Investigative Site, Créteil

Novartis Investigative Site, Paris

Novartis Investigative Site, Catania

Novartis Investigative Site, Genova

Novartis Investigative Site, Milan

Novartis Investigative Site, Roma

Novartis Investigative Site, London