A Stratified Sickle Event Randomized Trial (ASSERT)
Phase 3
Terminated
- Conditions
- Sickle Cell Disease
- Registration Number
- NCT00102791
- Lead Sponsor
- Icagen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 297
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Sickle Cell Crisis Rate 52 weeks
- Secondary Outcome Measures
Name Time Method Health Economics 52 Weeks Time to First, Second, and Third Crisis 52 Weeks Maximum Crisis Morbidity Ranking 52 Weeks Efficacy Related Laboratory Parameters 52 Weeks Quality of Life 52 Weeks