Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease
Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease
This is a clinical study evaluating the efficacy and safety of rivipansel (GMI-1070) in
 treating subjects with sickle cell disease (SCD) who are 6 years of age or older experiencing
 a pain crisis necessitating hospitalization.
Inclusion Criteria:

 -  At least 6 years of age.

 -  Documented diagnosis of sickle cell disease.

 -  Diagnosis of vaso-occlusive crisis necessitating admission to the hospital with
 treatment including IV opioids.

 -  Able to receive the first dose of study drug within 24 hours from the administration
 of IV opioids.

 Exclusion Criteria:

 -  Serious systemic infection

 -  Acute Chest Syndrome

 -  Serious concomitant medical problems (for example, stroke)

 -  SCD pain atypical of VOC

 -  Severe renal or hepatic impairment

 -  Chronic pain rather than a presentation of acute VOC