A Study of the Efficacy and Safety of ICA-17043 (With or Without Hydroxyurea) in Patients With Sickle Cell Anemia.
NCT ID: NCT00040677
Last Updated: 2011-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2002-02-28
2004-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ICA-17043 Low Dose 6 mg/day
Active study medication: 100 mg loading dose; 6 mg maintenance dose per day
Low Dose ICA-17043
Low dose arm
Placebo
Placebo
Placebo Loading dose capsules and maintenance dose tablets matched 10 mg active treatment group
ICA-17043 High Dose 10 mg/day
Active study medication: 150 mg loading dose; 10 mg maintenance dose per day
High dose ICA-17043
150 mg Loading Dose; 10 mg daily dose
Interventions
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Low Dose ICA-17043
Low dose arm
High dose ICA-17043
150 mg Loading Dose; 10 mg daily dose
Placebo
Placebo Loading dose capsules and maintenance dose tablets matched 10 mg active treatment group
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
60 Years
ALL
No
Sponsors
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Icagen
INDUSTRY
Responsible Party
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Icagen
Principal Investigators
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Kenneth I Ataga, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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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
Countries
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References
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Ataga KI, Smith WR, De Castro LM, Swerdlow P, Saunthararajah Y, Castro O, Vichinsky E, Kutlar A, Orringer EP, Rigdon GC, Stocker JW; ICA-17043-05 Investigators. Efficacy and safety of the Gardos channel blocker, senicapoc (ICA-17043), in patients with sickle cell anemia. Blood. 2008 Apr 15;111(8):3991-7. doi: 10.1182/blood-2007-08-110098. Epub 2008 Jan 11.
Related Links
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For more information about Icagen
For more information about Sickle Cell Disease
Other Identifiers
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ICA-17043-05
Identifier Type: -
Identifier Source: org_study_id
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