Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease

• Status: Completed
• Trial end date: 2019-06-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlycoMimetics Incorporated; Pfizer

Criteria

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