A Study Evaluating the Long-Term Safety of ICA-17043 in Sickle Cell Disease Patients With or Without Hydroxyurea Therapy
Public ClinicalTrials.gov record NCT00294541. 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
An Open-Label Extension Study Evaluating the Long-Term Safety of ICA-17043 With or Without Hydroxyurea Therapy in Subjects With Sickle Cell Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This trial is a follow-up companion study to Protocol ICA-17043-10, a Phase III, multi-center, efficacy and safety study of ICA-17043. This is an open-label extension study collecting safety data on the use of ICA-17043 in subjects with sickle cell disease (SCD) (e.g., HbSS, HbSC, HbSb0-thalassemia, HbSb+-thalassemia subjects). All subjects who have successfully completed ICA-17043-10 will, if deemed appropriate by their study Investigator and appropriate consent by subject is given, enroll in the ICA-17043-12 study (Study 12). Only patients who participated in ICA-17043-10 are eligible for this open label study
Study identification
- NCT ID
- NCT00294541
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 51 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 17 Years to 66 Years
- 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
- Jan 31, 2006
- Primary completion
- Not listed
- Completion
- May 31, 2007
- Last update posted
- Sep 10, 2007
2006 – 2007
United States locations
- U.S. sites
- 31
- U.S. states
- 20
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of South Alabama | Mobile | Alabama | 36617 | — |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | — |
| Children's Hospital Oakland | Oakland | California | 94609 | — |
| University of California Davis Medical Center | Sacramento | California | 95817 | — |
| University of Colorado Health Sciences Center | Denver | Colorado | 80262 | — |
| Century Clinical Research, Inc. | Holly Hill | Florida | 32117 | — |
| University of Florida Health Science Center | Jacksonville | Florida | 32209 | — |
| Medical College of Georgia | Augusta | Georgia | 30912 | — |
| Memorial Health University Medical Center | Savannah | Georgia | 31404 | — |
| University of Illinois Medical Center | Chicago | Illinois | 60612 | — |
| Sickle Cell Center of Northern Louisiana | Shreveport | Louisiana | 71103 | — |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21205 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Wayne State School of Medicine | Detroit | Michigan | 48201 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Robert Wood Johnson Medical Center | New Brunswick | New Jersey | 08903 | — |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112-2027 | — |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | — |
| New York Methodist Hospital | Brooklyn | New York | 11215 | — |
| University of North Carolina Hospitals | Chapel Hill | North Carolina | 27514 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| East Carolina University School of Medicine | Greenville | North Carolina | 27858 | — |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | — |
| University of Cincinnati | Cincinnati | Ohio | 45219 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134-1095 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Medical College of Virginia | Richmond | Virginia | 23298-0157 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00294541, 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 Sep 10, 2007 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00294541 live on ClinicalTrials.gov.