A Study Evaluating the Long-Term Safety of ICA-17043 in Sickle Cell Disease Patients With or Without Hydroxyurea Therapy
NCT ID: NCT00294541
Last Updated: 2007-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
51 participants
INTERVENTIONAL
2006-02-28
2007-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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ICA-17043
Eligibility Criteria
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Inclusion Criteria
* Discontinued Study 10 or 12 following the DMC recommendations because he/she was not on HU, and has since been on a stable dose of HU for at least 3 months prior to Day 1
* Male, or female not capable of becoming pregnant or using appropriate birth control
* Has willingly given written informed consent to participate in this study
Exclusion Criteria
* The subject is presently unsuitable for participation in this long-term study
17 Years
66 Years
ALL
No
Sponsors
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Icagen
INDUSTRY
Principal Investigators
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Jonathan W Stocker, PhD
Role: STUDY_DIRECTOR
Icagen
Locations
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University of South Alabama
Mobile, Alabama, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's Hospital Oakland
Oakland, California, United States
University of California Davis Medical Center
Sacramento, California, United States
University of Colorado Health Sciences Center
Denver, Colorado, United States
Century Clinical Research, Inc.
Holly Hill, Florida, United States
University of Florida Health Science Center
Jacksonville, Florida, United States
Medical College of Georgia
Augusta, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
University of Illinois Medical Center
Chicago, Illinois, United States
Sickle Cell Center of Northern Louisiana
Shreveport, Louisiana, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Wayne State School of Medicine
Detroit, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Robert Wood Johnson Medical Center
New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
New York Methodist Hospital
Brooklyn, New York, United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
East Carolina University School of Medicine
Greenville, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baylor College of Medicine
Houston, Texas, United States
Medical College of Virginia
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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Other Identifiers
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ICA-17043-12
Identifier Type: -
Identifier Source: org_study_id