A Stratified Sickle Event Randomized Trial (ASSERT)

Stopped early · Phase 3

Conditions studied: Sickle Cell Disease

In brief

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.

Key facts

Study ID

NCT00102791

Run by

Icagen

People needed

297

Starts

2005-02-01

Expected to finish

2007-06-01

Last updated by the study team

2008-03-27

Who can join

Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Davis, California, United States
• Study site — Los Angeles, California, United States
• Study site — Oakland, California, United States
• Study site — Denver, Colorado, United States
• Study site — Hartford, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Holly Hill, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Savannah, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Iowa City, Iowa, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Jackson, Mississippi, United States
• Study site — Kansas City, Missouri, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Hackensack, New Jersey, United States
• Study site — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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