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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
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
Safety measures only
Time frame: at least 60 weeks
No efficacy outcome measures
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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
...and 21 more locations