Study Stopped
Because of the low probability of achieving the primary endpoint.
A Stratified Sickle Event Randomized Trial (ASSERT)
ASSERT
A Phase III Multicenter, 52-Week, Randomized, Double-Blind, Placebo-Controlled Study of the Clinical Efficacy and Safety of ICA-17043 With or Without HU Therapy in Patients With Sickle Cell Disease Who Have Had =>2 Acute Sickle-Related Painful Crises Within the Preceding 12 Months
1 other identifier
interventional
297
6 countries
49
Brief Summary
The purpose of this study is to compare the effects of ICA-17043 to placebo with or without hydroxyurea (an oral drug used for treatment of sickle cell disease) in patients with sickle cell disease who have had 2 or more acute sickle-related painful crises requiring a visit to a medical facility within the past 12 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2005
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2005
CompletedStudy Start
First participant enrolled
February 1, 2005
CompletedFirst Posted
Study publicly available on registry
February 2, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedMarch 27, 2008
September 1, 2007
February 1, 2005
March 26, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sickle Cell Crisis Rate
52 weeks
Secondary Outcomes (5)
Time to First, Second, and Third Crisis
52 Weeks
Maximum Crisis Morbidity Ranking
52 Weeks
Efficacy Related Laboratory Parameters
52 Weeks
Quality of Life
52 Weeks
Health Economics
52 Weeks
Interventions
Eligibility Criteria
You may qualify if:
- to 65 years of age (inclusive)
- Male or female (not capable of becoming pregnant or using appropriate birth control)
- Medical history of sickle cell disease
- Have a history of at least two or more acute sickle-related painful crises requiring a visit to a medical facility within the preceding 12 months
You may not qualify if:
- Hemoglobin \<4 or \>11 g/dL
- On a chronic transfusion program
- Has significant active and poorly controlled (unstable) cardiovascular, neurologic, endocrine, hepatic, or renal disorders clearly unrelated to sickle cell disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Unknown Facility
Mobile, Alabama, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Davis, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Oakland, California, United States
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Denver, Colorado, United States
Unknown Facility
Hartford, Connecticut, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Holly Hill, Florida, United States
Unknown Facility
Hollywood, Florida, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Augusta, Georgia, United States
Unknown Facility
Savannah, Georgia, United States
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Chicago, Illinois, United States
Unknown Facility
Iowa City, Iowa, United States
Unknown Facility
New Orleans, Louisiana, United States
Unknown Facility
Shreveport, Louisiana, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Detroit, Michigan, United States
Unknown Facility
Jackson, Mississippi, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Hackensack, New Jersey, United States
Unknown Facility
New Brunswick, New Jersey, United States
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Newark, New Jersey, United States
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Brooklyn, New York, United States
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The Bronx, New York, United States
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Chapel Hill, North Carolina, United States
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Durham, North Carolina, United States
Unknown Facility
Greenville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Richmond, Virginia, United States
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Porto Alegre, Brazil
Unknown Facility
Rio de Janeiro, Brazil
Unknown Facility
São Paulo, Brazil
Unknown Facility
Créteil, France
Unknown Facility
Kingston, Jamaica
Unknown Facility
Port of Spain, Trinidad and Tobago
Unknown Facility
London, United Kingdom
Related Publications (1)
Stocker JW, De Franceschi L, McNaughton-Smith GA, Corrocher R, Beuzard Y, Brugnara C. ICA-17043, a novel Gardos channel blocker, prevents sickled red blood cell dehydration in vitro and in vivo in SAD mice. Blood. 2003 Mar 15;101(6):2412-8. doi: 10.1182/blood-2002-05-1433. Epub 2002 Nov 14.
PMID: 12433690BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jonathan W Stocker, Ph.D.
Icagen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 1, 2005
First Posted
February 2, 2005
Study Start
February 1, 2005
Study Completion
June 1, 2007
Last Updated
March 27, 2008
Record last verified: 2007-09