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Sponsored by: |
Icagen |
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Information provided by: | Icagen |
ClinicalTrials.gov Identifier: | NCT00040677 |
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 | Intervention | Phase |
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Sickle Cell Disease Sickle Cell Anemia |
Drug: ICA-17043 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Multicenter, Twelve-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Range-Finding Study of the Efficacy and Safety of ICA-17043 With or Without Hydroxyurea Therapy in Patients With Sickle Cell Anemia |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
Study Site | |
Birmingham, Alabama, United States | |
United States, California | |
Study Site | |
Oakland, California, United States | |
Study Site | |
San Francisco, California, United States | |
United States, District of Columbia | |
Study Site | |
Washington, District of Columbia, United States | |
United States, Georgia | |
Study Site | |
Augusta, Georgia, United States | |
United States, Illinois | |
Study Site | |
Chicago, Illinois, United States | |
United States, Maryland | |
Study Site | |
Baltimore, Maryland, United States | |
United States, Massachusetts | |
Study Site | |
Boston, Massachusetts, United States | |
United States, Michigan | |
Study Site | |
Detroit, Michigan, United States | |
United States, Mississippi | |
Study Site | |
Jackson, Mississippi, United States | |
United States, New York | |
Study Site | |
New York, New York, United States | |
Study Site | |
Brooklyn, New York, United States | |
United States, North Carolina | |
Study Site | |
Chapel Hill, North Carolina, United States | |
Study Site | |
Durham, North Carolina, United States | |
United States, Pennsylvania | |
Study Site | |
Pittsburgh, Pennsylvania, United States | |
Study Site | |
Philadelphia, Pennsylvania, United States | |
United States, Tennessee | |
Study Site | |
Nashville, Tennessee, United States | |
United States, Texas | |
Study Site | |
Houston, Texas, United States | |
United States, Virginia | |
Study Site | |
Richmond, Virginia, United States |
Study ID Numbers: | ICA-17043-05 |
Study First Received: | July 8, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00040677 |
Health Authority: | United States: Food and Drug Administration |
sickle cell anemia sickle cell disease anemia ICA-17043 |
Anemia, Hemolytic, Congenital Signs and Symptoms Genetic Diseases, Inborn Hydroxyurea Hematologic Diseases Hemoglobinopathies |
Anemia Anemia, Hemolytic Hemoglobinopathy Anemia, Sickle Cell Sickle cell anemia |
Antisickling Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Hematologic Agents Enzyme Inhibitors Nucleic Acid Synthesis Inhibitors Pharmacologic Actions |