Status:
TERMINATED
A Study Evaluating the Long-Term Safety of ICA-17043 in Sickle Cell Disease Patients With or Without Hydroxyurea Therapy
Lead Sponsor:
Icagen
Collaborating Sponsors:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Sickle Cell Disease
Sickle Cell Anemia
Eligibility:
All Genders
17-66 years
Phase:
PHASE3
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00294541
Start Date
February 1 2006
End Date
June 1 2007
Last Update
September 11 2007
Active Locations (31)
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1
University of South Alabama
Mobile, Alabama, United States, 36617
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
3
Children's Hospital Oakland
Oakland, California, United States, 94609
4
University of California Davis Medical Center
Sacramento, California, United States, 95817