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
1 other identifier
interventional
90
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2002
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedFirst Submitted
Initial submission to the registry
July 8, 2002
CompletedFirst Posted
Study publicly available on registry
July 10, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2004
CompletedJuly 18, 2011
July 1, 2011
1.7 years
July 8, 2002
July 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary efficacy endpoint was the change from Baseline in hemoglobin (Hb)
12 Weeks
Secondary Outcomes (11)
Changes in other hematologic measurements
12 weeks
Changes in RBC indices, including: mean corpuscular volume (MCV), mean corpuscular Hb concentration (MCHC), and mean corpuscular Hb (MCH
12 weeks
Other laboratory measures associated with sickle cell crises activity including: direct and indirect bilirubin and lactic dehydrogenase (LDH)
12 weeks
Rate of painful crises
12 weeks
Time to first painful crisis
12 weeks
- +6 more secondary outcomes
Study Arms (3)
ICA-17043 Low Dose 6 mg/day
EXPERIMENTALActive study medication: 100 mg loading dose; 6 mg maintenance dose per day
Placebo
PLACEBO COMPARATORICA-17043 High Dose 10 mg/day
EXPERIMENTALActive study medication: 150 mg loading dose; 10 mg maintenance dose per day
Interventions
Placebo Loading dose capsules and maintenance dose tablets matched 10 mg active treatment group
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Icagenlead
Study Sites (19)
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
Related Publications (1)
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.
PMID: 18192510RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth I Ataga, MD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 8, 2002
First Posted
July 10, 2002
Study Start
February 1, 2002
Primary Completion
November 1, 2003
Study Completion
January 1, 2004
Last Updated
July 18, 2011
Record last verified: 2011-07