Sickle Cell Disease and Vaso-occlusive Crisis Treatment With Rivipansel – Phase III

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

Protocol Description

The purpose of this study is to determine whether the drug rivipansel is safe and effective for treating vaso-occlusive crisis (VOC) in hospitalized people with sickle cell disease. A VOC is a common and painful complication of sickle cell anemia that occurs when blood circulation is obstructed by sickled red blood cells. In a previous smaller study, patients who received rivipansel had a shorter duration of VOC than those who received placebo.

Study Level: Phase III

Eligibility Criteria

This study is enrolling participants of both genders, ages 6 and older, who have sickle cell disease and are being treated for VOC in a hospital setting. In some cases participants may be enrolled by their doctor prior to having a VOC incident, in anticipation of a future event.
Males and Females: Ages 6 and older


During hospitalization for the VOC, the patient will be given a physical, including a pain assessment. Eligible patients will be provided either rivipansel or a placebo, which will be administered intravenously (via IV) within 24 hours of the start of IV opioids. Dosing will continue every 12 hours until the patient no longer requires IV pain medication. Patient monitoring, blood and other tests will occur during the dosing period. After discharge from the hospital, follow up will be done by telephone or office visits.
Visits: Requires hospitalization
Duration: Approximately 44 days from the time of hospitalization

Status: Enrolling by invitation only

Source(s) of Support


Primary Investigator

Cheryl A. Hillery, MD

Contact Information

For more information about the study or enrollment, please contact:
Angela Martino, BSN, RN