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A study of the efficacy and safety of ICA-17043 (with or without hydroxyurea) in patients with sickle cell anemia. Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about A study of the efficacy and safety of ICA-17043 (with or without hydroxyurea) in patients with sickle cell anemia. conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A study of the efficacy and safety of ICA-17043 (with or without hydroxyurea) in patients with sickle cell anemia. Clinical research trials and A study of the efficacy and safety of ICA-17043 (with or without hydroxyurea) in patients with sickle cell anemia. health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A study of the efficacy and safety of ICA-17043 (with or without hydroxyurea) in patients with sickle cell anemia.. A study of the efficacy and safety of ICA-17043 (with or without hydroxyurea) in patients with sickle cell anemia. Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a A study of the efficacy and safety of ICA-17043 (with or without hydroxyurea) in patients with sickle cell anemia. clinical trial. Human subjects often get the best healthcare possible for their A study of the efficacy and safety of ICA-17043 (with or without hydroxyurea) in patients with sickle cell anemia. condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A study of the efficacy and safety of ICA-17043 (with or without hydroxyurea) in patients with sickle cell anemia.  A study of the efficacy and safety of ICA-17043 (with or without hydroxyurea) in patients with sickle cell anemia.
A study of the efficacy and safety of ICA-17043 (with or without hydroxyurea) in patients with sickle cell anemia.
For Condition: Sickle Cell Anemia,Sickle Cell Disease
Status: Completed
Sponsor(s): Icagen ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 90
Location and Contact Information:
Study Site
Chapel Hill, North Carolina,
United States
Study Site
Chicago, Illinois,
United States
Study Site
San Francisco, California,
United States
Study Site
Houston, Texas,
United States
Study Site
Birmingham, Alabama,
United States
Study Site
Jackson, Mississippi,
United States
Study Site
Boston, Massachusetts,
United States
Study Site
Augusta, Georgia,
United States
Study Site
Durham, North Carolina,
United States
Study Site
New York City, New York,
United States
Study Site
Detroit, Michigan,
United States
Study Site
Brooklyn, New York,
United States
Study Site
Richmond, Virginia,
United States
Study Site
Nashville, Tennessee,
United States
Study Site
Philadelphia, Pennsylvania,
United States
Study Site
Pittsburgh, Pennsylvania,
United States
Study Site
Baltimore, Maryland,
United States
Study Site
Oakland, California,
United States
Study Site
Washington D.C., District of Columbia,
United States
Additional Information:
Study ID Numbers: ICA-17043-05;
Study Start Date: February 2002
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040677
Other Sickle Cell Anemia Studies:
1. Nitric Oxide to Improve Blood Flow in Sickle Cell Disease
2. Bone Marrow Transplantation in Treating Children With Sickle Cell Disease
3. Silent Cerebral Infarct Multi-Center Clinical Trial
4. Pilot Study of Fructose for Sickle Cell Crisis
5. Hydroxyurea for the Treatment of Patients with Sickle Cell Anemia
Related Studies:
Other Sickle Cell Anemia Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
A study of the efficacy and safety of ICA-17043 (with or without hydroxyurea) in patients with sickle cell anemia.
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