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A Stratified Sickle Event Randomized Trial (ASSERT)

This study has been terminated.
(Because of the low probability of achieving the primary endpoint.)
Sponsor:
Collaborator:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by:
Icagen
ClinicalTrials.gov Identifier:
NCT00102791
First received: February 1, 2005
Last updated: March 26, 2008
Last verified: September 2007
History of Changes
  Purpose

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 Intervention Phase
Sickle Cell Disease
 Drug: ICA-17043
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Icagen:

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

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

Enrollment: 297
Study Start Date: February 2005
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Icagen webpage  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00102791     History of Changes
Other Study ID Numbers: ICA-17043-10
Study First Received: February 1, 2005
Last Updated: March 26, 2008
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013