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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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.
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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

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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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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 identifier (NCT number): NCT00294541

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Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Study Director: Jonathan W Stocker, PhD Icagen

Layout table for additonal information Identifier: NCT00294541    
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:
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Anemia, Sickle Cell
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Genetic Diseases, Inborn
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors