A Study Evaluating the Long-Term Safety of ICA-17043 in Sickle Cell Disease Patients With or Without Hydroxyurea Therapy

Stopped early · Phase 3

Conditions studied: Sickle Cell Disease, Sickle Cell Anemia

In brief

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

Key facts

Study ID

NCT00294541

Run by

Icagen

People needed

51

Starts

2006-02-01

Expected to finish

2007-06-01

Last updated by the study team

2007-09-11

Who can join

Age: 17 and older, up to 66. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Successfully completed Study ICA-17043-10
• 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

You may not qualify if…

• The subject, if female, has a positive urine pregnancy test on Day 1 (before entering study)
• The subject is presently unsuitable for participation in this long-term study

Where it is running

• 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

Full record on ClinicalTrials.gov

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