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.

Condition	Treatment or Intervention	Phase
Sickle Cell Disease Sickle Cell Anemia	Drug: ICA-17043	Phase II

Further Study Details: 

Expected Total Enrollment:  90

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

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

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

Study ID Numbers:  ICA-17043-05
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  July 8, 2002
ClinicalTrials.gov Identifier:  NCT00040677
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08