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

This study has been completed.

First Received: July 8, 2002 Last Updated: June 23, 2005 History of Changes

Sponsor:	Icagen
Information provided by:	Icagen
ClinicalTrials.gov Identifier:	NCT00040677

Purpose

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
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

Resource links provided by NLM:

Genetics Home Reference related topics: sickle cell disease

MedlinePlus related topics: Anemia Sickle Cell Anemia

Drug Information available for: ICA 17043 Hydroxyurea

U.S. FDA Resources

Further study details as provided by Icagen:

Estimated Enrollment:	90
Study Start Date:	February 2002

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00040677

Locations

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

Sponsors and Collaborators

Icagen

More Information

Additional Information:

For more information about Icagen This link exits the ClinicalTrials.gov site

For more information about Sickle Cell Disease This link exits the ClinicalTrials.gov site

No publications provided by Icagen

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	ICA-17043-05
Study First Received:	July 8, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00040677 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Icagen:

sickle cell anemia
sickle cell disease
anemia
ICA-17043

Additional relevant MeSH terms:

Antisickling Agents
Molecular Mechanisms of Pharmacological Action
Hematologic Diseases
Hydroxyurea
Antineoplastic Agents
Hematologic Agents
Anemia
Anemia, Hemolytic

Enzyme Inhibitors
Pharmacologic Actions
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hemoglobinopathies
Therapeutic Uses
Anemia, Sickle Cell
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 27, 2009