Evaluation of the Safety, Tolerability, Pharmacokinetics (PK) and Effects on Liver Iron Concentration of ICL670 Relative to Deferoxamine(DFO).
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.
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
- Enrollment
- 185 participants
Conditions and interventions
Conditions
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
- Jun 30, 2004
- Primary completion
- Jun 30, 2009
- Completion
- Not listed
- Last update posted
- Jun 5, 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 5, 2011 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01090323 live on ClinicalTrials.gov.