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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT01090323

Public ClinicalTrials.gov record NCT01090323. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 9:56 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A One Year Open Label, Non-comparative Extension to a Randomized, Multicenter, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Effects on Liver Iron Concentration (LIC) of Repeated Doses of 5-30mg/kg/Day ICL670 Relative to Deferoxamine (DFO) in Sickle Cell Disease (SCD) Patients With Transfusional Hemosideresis (THS) [Amendment 3: Extension Prolonged to 4-years]

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The safety, tolerability, effects on liver iron concentration and pharmacokinetics of ICL670 is studied in sickle cell disease patients with transfusional hemosiderosis.

Study identification

NCT ID
NCT01090323
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
185 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
2 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2004 (Type not available)
Primary completion
Jul 2009 (Actual)
Completion
Not listed
Last update posted
Jun 6, 2011

Started 2004

United States locations

U.S. sites
31
U.S. states
18
U.S. cities
28
Facility City State ZIP Site status
University of South Alabama College of Medicine Mobile Alabama 36604 —
Loma Linda University Medical Center Loma Linda California 92354 —
Children's Hospital Los Angeles Los Angeles California 90027 —
Children's Hospital & Research Center at Oakland Oakland California 90609 —
University of Colorado Health Science Center Denver Colorado 80262 —
Howard University Hospital Washington D.C. District of Columbia 20059 —
St Joseph Children's Hospital of Tampa Tampa Florida 33607 —
Grady Hospital, Georgia Comprehensive Sickle Cell Center Atlanta Georgia 30303 —
Medical College of Georgia Augusta Georgia 30912 —
University of Illinois at Chicago Chicago Illinois 60612 —
Children's Memorial Hospital Chicago Illinois 60614 —
Tulane University Medical Center New Orleans Louisiana 70112 —
LSUHSC Dept of Pediatrics Shreveport Louisiana 71130 —
Children's Hospital Boston Boston Massachusetts 02118 —
Karmanos Cancer Institute Detroit Michigan 48201 —
New York Methodist Hospital Brooklyn New York 11215 —
New York Presbyterian Hospital New York New York 10021 —
Montefiore Medical Center The Bronx New York 10467 —
Wake Forest University Health Sciences Winston-Salem North Carolina 27157 —
Children's Hospital Medical Center Cincinnati Ohio 45229 —
University of Cincinnati Cincinnati Ohio 45267 —
Milton S. Hershey Medical Center Hershey Pennsylvania 17033 —
Yasin Philadelphia Pennsylvania 19104 —
Children's Hospital of Pittsburgh Pittsburgh Pennsylvania 15213 —
Palmetto Health Richland Columbia South Carolina 29203 —
Santee Hematology/Oncology Sumter South Carolina 29150 —
St. Jude's Children Research Hospital Memphis Tennessee 38105 —
Texas Children's Hospital Houston Texas 77030 —
The Methodist Hospital Houston Texas 77030 —
Scott & White Memorial Hospital Temple Texas 76508 —
Children's Hospital of the King's Daughters Norfolk Virginia 23507 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01090323, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 6, 2011 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01090323 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →