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A Stratified Sickle Event Randomized Trial (ASSERT) (ASSERT)

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ClinicalTrials.gov Identifier: NCT00102791
Recruitment Status : Terminated (Because of the low probability of achieving the primary endpoint.)
First Posted : February 2, 2005
Last Update Posted : March 27, 2008
Sponsor:
Collaborator:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by:
Icagen

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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Drug: ICA-17043 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 297 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : February 2005
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Sickle Cell Crisis Rate [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Time to First, Second, and Third Crisis [ Time Frame: 52 Weeks ]
  2. Maximum Crisis Morbidity Ranking [ Time Frame: 52 Weeks ]
  3. Efficacy Related Laboratory Parameters [ Time Frame: 52 Weeks ]
  4. Quality of Life [ Time Frame: 52 Weeks ]
  5. Health Economics [ Time Frame: 52 Weeks ]


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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102791


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Locations
United States, Alabama
Mobile, Alabama, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Davis, California, United States
Los Angeles, California, United States
Oakland, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Connecticut
Hartford, Connecticut, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Holly Hill, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
United States, Georgia
Augusta, Georgia, United States
Savannah, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Iowa
Iowa City, Iowa, United States
United States, Louisiana
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Detroit, Michigan, United States
United States, Mississippi
Jackson, Mississippi, United States
United States, Missouri
Kansas City, Missouri, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Jersey
Hackensack, New Jersey, United States
New Brunswick, New Jersey, United States
Newark, New Jersey, United States
United States, New York
Bronx, New York, United States
Brooklyn, New York, United States
United States, North Carolina
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
Greenville, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, Tennessee
Memphis, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Houston, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Richmond, Virginia, United States
Brazil
Porto Alegre, Brazil
Rio de Janeiro, Brazil
Sao Paulo, Brazil
France
Creteil, France
Jamaica
Kingston, Jamaica
Trinidad and Tobago
Port of Spain, Trinidad and Tobago
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Icagen
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Investigators
Study Director: Jonathan W Stocker, Ph.D. Icagen

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00102791     History of Changes
Other Study ID Numbers: ICA-17043-10
First Posted: February 2, 2005    Key Record Dates
Last Update Posted: March 27, 2008
Last Verified: September 2007

Keywords provided by Icagen:
Sickle Cell Anemia

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn