drugset / Trial / NCT00294541
A Study Evaluating the Long-Term Safety of ICA-17043 in Sickle Cell Disease Patients With or Without Hydroxyurea Therapy
Phase 3
Terminated
51 enrolled
Icagen
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · collab
Non-randomizedSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2006-02
- Primary completion
- —
- Completion
- 2007-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Senicapoc | Small molecule | — | — |