Sickle Cell Anemia, Sickle Cell Disease
Conditions
Keywords
sickle cell disease, sickle cell anemia
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
Interventions
DRUGICA-17043
Sponsors
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Icagen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
17 Years to 66 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety measures only | at least 60 weeks |
| No efficacy outcome measures | — |
Countries
United States
Outcome results
None listed