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

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ClinicalTrials.gov Identifier: NCT00294541
Recruitment Status : Terminated (Lack of efficacy demonstrated in study ICA-17043-10)
First Posted : February 22, 2006
Last Update Posted : September 11, 2007
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:
Icagen

Brief 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

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Sickle Cell Anemia Drug: ICA-17043 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2006
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Hydroxyurea




Primary Outcome Measures :
  1. Safety measures only [ Time Frame: at least 60 weeks ]
  2. No efficacy outcome measures


Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 66 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00294541


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Locations
United States, Alabama
University of South Alabama
Mobile, Alabama, United States, 36617
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
Children's Hospital Oakland
Oakland, California, United States, 94609
University of California Davis Medical Center
Sacramento, California, United States, 95817
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
United States, Florida
Century Clinical Research, Inc.
Holly Hill, Florida, United States, 32117
University of Florida Health Science Center
Jacksonville, Florida, United States, 32209
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
United States, Illinois
University of Illinois Medical Center
Chicago, Illinois, United States, 60612
United States, Louisiana
Sickle Cell Center of Northern Louisiana
Shreveport, Louisiana, United States, 71103
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
Wayne State School of Medicine
Detroit, Michigan, United States, 48201
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Robert Wood Johnson Medical Center
New Brunswick, New Jersey, United States, 08903
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112-2027
United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
New York Methodist Hospital
Brooklyn, New York, United States, 11215
United States, North Carolina
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27514
Duke University Medical Center
Durham, North Carolina, United States, 27710
East Carolina University School of Medicine
Greenville, North Carolina, United States, 27858
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45219
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134-1095
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Virginia
Medical College of Virginia
Richmond, Virginia, United States, 23298-0157
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Icagen
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Jonathan W Stocker, PhD Icagen

ClinicalTrials.gov Identifier: NCT00294541     History of Changes
Other Study ID Numbers: ICA-17043-12
First Posted: February 22, 2006    Key Record Dates
Last Update Posted: September 11, 2007
Last Verified: September 2007

Keywords provided by Icagen:
sickle cell disease
sickle cell anemia

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Hydroxyurea
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors