A Study Evaluating the Long-Term Safety of ICA-17043 in Sickle Cell Disease Patients With or Without Hydroxyurea Therapy

• Status: Terminated
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icagen
• Collaborator: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Hydroxyurea

Criteria

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