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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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:
Information provided by:

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.

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

Study Design

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
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, 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
Contacts and Locations

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


  Show 49 Study Locations
Sponsors and Collaborators
Icagen
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Investigators
Study Director: Jonathan W Stocker, Ph.D. Icagen
More Information

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