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

March 26, 2008 updated by: Icagen

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

297

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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
  • United States
    • Alabama
      • Mobile, Alabama, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Davis, California, United States
      • Los Angeles, California, United States
      • Oakland, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Connecticut
      • Hartford, Connecticut, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Holly Hill, Florida, United States
      • Hollywood, Florida, United States
      • Jacksonville, Florida, United States
    • Georgia
      • Augusta, Georgia, United States
      • Savannah, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Iowa
      • Iowa City, Iowa, United States
    • Louisiana
      • New Orleans, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
    • Mississippi
      • Jackson, Mississippi, United States
    • Missouri
      • Kansas City, Missouri, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Hackensack, New Jersey, United States
      • New Brunswick, New Jersey, United States
      • Newark, New Jersey, United States
    • New York
      • Bronx, New York, United States
      • Brooklyn, New York, 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
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
    • Tennessee
      • Memphis, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Richmond, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sickle Cell Crisis Rate
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icagen

Collaborators

McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Investigators

  • Study Director: Jonathan W Stocker, Ph.D., Icagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion

December 7, 2022

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

February 1, 2005

First Submitted That Met QC Criteria

February 1, 2005

First Posted (Estimate)

February 2, 2005

Study Record Updates

Last Update Posted (Estimate)

March 27, 2008

Last Update Submitted That Met QC Criteria

March 26, 2008

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICA-17043-10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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