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

Last updated: September 10, 2007
Sponsor: Icagen
Overall Status: Terminated

Phase

3

Condition

Anemia

Sickle Cell Disease

Red Blood Cell Disorders

Treatment

N/A

Clinical Study ID

NCT00294541
ICA-17043-12
  • Ages 17-66
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Successfully completed Study ICA-17043-10

  • Discontinued Study 10 or 12 following the DMC recommendations because he/she was noton 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

Exclusion Criteria:

  • The subject, if female, has a positive urine pregnancy test on Day 1 (before enteringstudy)

  • The subject is presently unsuitable for participation in this long-term study

Study Design

Total Participants: 51
Study Start date:
February 01, 2006
Estimated Completion Date:
June 30, 2007

Connect with a study center

  • University of South Alabama

    Mobile, Alabama 36617
    United States

    Site Not Available

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Children's Hospital Oakland

    Oakland, California 94609
    United States

    Site Not Available

  • University of California Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • University of Colorado Health Sciences Center

    Denver, Colorado 80262
    United States

    Site Not Available

  • Century Clinical Research, Inc.

    Holly Hill, Florida 32117
    United States

    Site Not Available

  • University of Florida Health Science Center

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Medical College of Georgia

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Memorial Health University Medical Center

    Savannah, Georgia 31404
    United States

    Site Not Available

  • University of Illinois Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Sickle Cell Center of Northern Louisiana

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Wayne State School of Medicine

    Detroit, Michigan 48201
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Robert Wood Johnson Medical Center

    New Brunswick, New Jersey 08903
    United States

    Site Not Available

  • Newark Beth Israel Medical Center

    Newark, New Jersey 07112-2027
    United States

    Site Not Available

  • New York Methodist Hospital

    Brooklyn, New York 11215
    United States

    Site Not Available

  • SUNY Downstate Medical Center

    Brooklyn, New York 11203
    United States

    Site Not Available

  • University of North Carolina Hospitals

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • East Carolina University School of Medicine

    Greenville, North Carolina 27858
    United States

    Site Not Available

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • St. Christopher's Hospital for Children

    Philadelphia, Pennsylvania 19134-1095
    United States

    Site Not Available

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Medical College of Virginia

    Richmond, Virginia 23298-0157
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Site Not Available

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