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

Tracking Information
First Received Date ^ICMJE	July 8, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	February 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00040677 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study of the Efficacy and Safety of ICA-17043 (With or Without Hydroxyurea) in Patients With Sickle Cell Anemia.
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Sickle Cell Disease Sickle Cell Anemia
Intervention ^ICMJE	Drug: ICA-17043
Study Arms / Comparison Groups
Publications *	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. Epub 2008 Jan 11.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	90
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00040677
Responsible Party
Study ID Numbers ^ICMJE	ICA-17043-05
Study Sponsor ^ICMJE	Icagen
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Icagen
Verification Date	September 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP