TerminatedPhase 3

A Stratified Sickle Event Randomized Trial (ASSERT)

Stopped: Because of the low probability of achieving the primary endpoint.

United States297 participantsStarted 2005-02

Plain-language 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.

Who can participate

Age range16 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Sickle Cell Crisis Rate

Timeframe: 52 weeks

Trial details

NCT IDNCT00102791

SponsorIcagen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Sickle Cell Disease trials