A Study Evaluating the Long-Term Safety of ICA-17043 in Sickle Cell Disease Patients With or Without Hydroxyurea Therapy
- Conditions
- Sickle Cell DiseaseSickle Cell Anemia
- Registration Number
- NCT00294541
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 51
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety measures only at least 60 weeks No efficacy outcome measures
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (31)
University of South Alabama
🇺🇸Mobile, Alabama, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Children's Hospital Oakland
🇺🇸Oakland, California, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
Century Clinical Research, Inc.
🇺🇸Holly Hill, Florida, United States
University of Florida Health Science Center
🇺🇸Jacksonville, Florida, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
University of Illinois Medical Center
🇺🇸Chicago, Illinois, United States
Scroll for more (21 remaining)University of South Alabama🇺🇸Mobile, Alabama, United States