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

Completed · Phase 2 · Has a placebo group

Conditions studied: Sickle Cell Disease, Sickle Cell Anemia

In brief

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.

Key facts

Study ID

NCT00040677

Run by

Icagen

People needed

90

Starts

2002-02-01

Expected to finish

2004-01-01

Last updated by the study team

2011-07-18

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study Site — Birmingham, Alabama, United States
• Study Site — Oakland, California, United States
• Study Site — San Francisco, California, United States
• Study Site — Washington D.C., District of Columbia, United States
• Study Site — Augusta, Georgia, United States
• Study Site — Chicago, Illinois, United States
• Study Site — Baltimore, Maryland, United States
• Study Site — Boston, Massachusetts, United States
• Study Site — Detroit, Michigan, United States
• Study Site — Jackson, Mississippi, United States
• Study Site — Brooklyn, New York, United States
• Study Site — New York, New York, United States
• Study Site — Chapel Hill, North Carolina, United States
• Study Site — Durham, North Carolina, United States
• Study Site — Philadelphia, Pennsylvania, United States
• Study Site — Pittsburgh, Pennsylvania, United States
• Study Site — Nashville, Tennessee, United States
• Study Site — Houston, Texas, United States
• Study Site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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