A Stratified Sickle Event Randomized Trial (ASSERT)

Icagen

Status and phase

Terminated

Phase 3

Conditions

Sickle Cell Disease

Treatments

Drug: ICA-17043

Study type

Interventional

Funder types

Industry

Identifiers

NCT00102791

ICA-17043-10

Details and patient eligibility

About

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.

Enrollment

297 patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

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