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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
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:

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
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Hydroxyurea
U.S. FDA Resources

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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Show 31 Study Locations
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
Hematologic Diseases
Genetic Diseases, Inborn
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors