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

This study has been terminated.
(Lack of efficacy demonstrated in study ICA-17043-10)
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:
Icagen
ClinicalTrials.gov Identifier:
NCT00294541
First received: February 21, 2006
Last updated: September 10, 2007
Last verified: September 2007
History of Changes
  Purpose

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 Intervention Phase
Sickle Cell Disease
Sickle Cell Anemia
 Drug: ICA-17043
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by Icagen:

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

Enrollment: 51
Study Start Date: February 2006
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   17 Years to 66 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00294541

  Show 31 Study Locations
Sponsors and Collaborators
Icagen
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Jonathan W Stocker, PhD Icagen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00294541     History of Changes
Other Study ID Numbers: ICA-17043-12
Study First Received: February 21, 2006
Last Updated: September 10, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Icagen:
sickle cell disease
sickle cell anemia

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

ClinicalTrials.gov processed this record on June 18, 2013