Trial | NCT00040677  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    senicapoc ...

  • Study Participants

    90
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.
Study Started
Feb 28
2002
Primary Completion
Nov 30
2003
Study Completion
Jan 31
2004
Last Update
Jul 18
2011
Estimate

Drug Low Dose ICA-17043

Low dose arm

Drug High dose ICA-17043

150 mg Loading Dose; 10 mg daily dose

Drug Placebo

Placebo Loading dose capsules and maintenance dose tablets matched 10 mg active treatment group

ICA-17043 Low Dose 6 mg/day Experimental

Active study medication: 100 mg loading dose; 6 mg maintenance dose per day

Placebo Placebo Comparator

ICA-17043 High Dose 10 mg/day Experimental

Active study medication: 150 mg loading dose; 10 mg maintenance dose per day

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
No Results Posted