Back to resultsA Stratified Sickle Event Randomized Trial (ASSERT) (ASSERT)
Primary Purpose
Sickle Cell Disease
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ICA-17043
Sponsored by
About this trial
This is an interventional treatment trial for Sickle Cell Disease focused on measuring Sickle Cell Anemia
Eligibility Criteria
Inclusion Criteria: 16 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 Exclusion Criteria: 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
Sites / Locations
Outcomes
Primary Outcome Measures
Sickle Cell Crisis Rate
Secondary Outcome Measures
Time to First, Second, and Third Crisis
Maximum Crisis Morbidity Ranking
Efficacy Related Laboratory Parameters
Quality of Life
Health Economics
Full Information
NCT ID
NCT00102791
First Posted
February 1, 2005
Last Updated
March 26, 2008
Sponsor
Icagen
Collaborators
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00102791
Brief Title
A Stratified Sickle Event Randomized Trial (ASSERT)
Acronym
ASSERT
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Terminated
Why Stopped
Because of the low probability of achieving the primary endpoint.
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Icagen
Collaborators
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
Sickle Cell Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
297 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ICA-17043
Primary Outcome Measure Information:
Title
Sickle Cell Crisis Rate
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Time to First, Second, and Third Crisis
Time Frame
52 Weeks
Title
Maximum Crisis Morbidity Ranking
Time Frame
52 Weeks
Title
Efficacy Related Laboratory Parameters
Time Frame
52 Weeks
Title
Quality of Life
Time Frame
52 Weeks
Title
Health Economics
Time Frame
52 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
16 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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan W Stocker, Ph.D.
Organizational Affiliation
Icagen
Official's Role
Study Director
Facility Information:
City
Mobile
State/Province
Alabama
Country
United States
City
Little Rock
State/Province
Arkansas
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United States
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Davis
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California
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United States
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Los Angeles
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California
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Oakland
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Denver
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Colorado
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United States
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Hartford
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Connecticut
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United States
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Washington
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District of Columbia
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United States
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Holly Hill
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Florida
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United States
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Hollywood
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United States
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Jacksonville
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Florida
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United States
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Augusta
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Georgia
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United States
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Savannah
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Georgia
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Chicago
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Illinois
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United States
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Iowa City
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Iowa
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New Orleans
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Louisiana
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United States
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Shreveport
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Louisiana
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Baltimore
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Boston
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Detroit
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United States
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Jackson
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Mississippi
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Kansas City
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Missouri
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Las Vegas
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Nevada
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United States
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Hackensack
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New Jersey
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United States
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New Brunswick
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New Jersey
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United States
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Newark
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New Jersey
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United States
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Bronx
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New York
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United States
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Brooklyn
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New York
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Chapel Hill
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North Carolina
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United States
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Durham
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North Carolina
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Greenville
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United States
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Winston-Salem
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Cincinnati
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Ohio
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United States
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Cleveland
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Ohio
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United States
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Philadelphia
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United States
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Pittsburgh
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Charleston
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South Carolina
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United States
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Memphis
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Tennessee
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United States
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Nashville
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Tennessee
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Houston
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Texas
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United States
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San Antonio
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Texas
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United States
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Richmond
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Virginia
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United States
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Porto Alegre
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Brazil
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Rio de Janeiro
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Brazil
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Sao Paulo
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Brazil
City
Creteil
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France
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Kingston
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Jamaica
City
Port of Spain
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Trinidad and Tobago
City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
12433690
Citation
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.
Results Reference
background
Links:
URL
http://www.icagen.com
Description
Icagen webpage
Learn more about this trial
A Stratified Sickle Event Randomized Trial (ASSERT)
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