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