A Study of the Efficacy and Safety of ICA-17043 (With or Without Hydroxyurea) in Patients With Sickle Cell Anemia.

• Status: Completed
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: All

Summary

ICA-17043 is being developed for the chronic treatment of patients with sickle cell disease (SCD) in both adults and children. ICA-17043 is a potent and specific inhibitor of a channel in human red blood cells (RBCs) that blocks RBC dehydration. ICA-17043 is expected to inhibit RBC dehydration and thus should prevent or delay the sickling process. By reducing sickled cells, an improvement in anemia, a reduction in painful crises, and ultimately, less end-organ disease is anticipated.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icagen
• Treatments: Hydroxyurea

Criteria

Inclusion Criteria:

• Homozygous (HbSS) Sickle Cell Anemia

• Otherwise healthy (based on medical history, physical examination, 12-lead ECG, and clinical laboratory tests)

• Patients may be receiving hydroxyurea, but must have been dose stabilized for at least 3 months

• Patient has a history of at least one acute vaso-occlusive event requiring hospitalization

Exclusion Criteria:

• Patient participating in a chronic transfusion program

• Patient having a total hemoglobin of < 4.0 g/dL or > 10.0 g/dL

• Patient having a HbA > 10%

• Patient considering undergoing an elective surgery

• Patient taking prohibited medications such as Epoetin, Warfarin, etc.

• Patient who has had previous gastrointestinal surgery, except cholecystectomy or appendectomy

• Patient with significant active cardiovascular, neurologic, endocrine, hepatic, or renal disorders unrelated to sickle cell anemia