Efficacy & Safety of Rivipansel (GMI-10170) in Sickle Cell Pain

Name of Study: Safety Of Rivipansel (GMI-1070) In The Treatment Of One or More Vaso-occlusive Crises In Hospitalized Subjects With Sickle Cell Disease

Brief Summary: GMI-1070 in SCD: reduction in time to resolution of vaso-occlusive events and decreased opioid use. 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.

Intervention- (This is a phase 3 trial) Drug: Rivipansel and Other: Placebo

Age range: There are 2 cohorts in this study

• Cohort 1: includes one adult stratum (18 years old) and one pediatric stratum (12-17 years old)
• Cohort 2: includes one pediatric stratum (6-11 years old)

Eligibility

1. At least 6 years of age.
2. Documented diagnosis of sickle cell disease.
3. Diagnosis of vaso-occlusive crisis necessitating admission to the hospital with treatment including IV opioids.
4. Able to receive the first dose of study drug within 24 hours from the administration of IV opioids.

1. Serious systemic infection
2. Acute Chest Syndrome
3. Serious concomitant medical problems (for example, stroke)
4. SCD pain atypical of VOC
5. Severe renal or hepatic impairment
6. Chronic pain rather than a presentation of acute VOC

Sites in Ontario:

1. Children’s Hospital of Eastern Ontario, Ottawa, Ontario, Canada, K1H 8L1

2. The Hospital for Sick Children, Toronto, Ontario, Canada, M5G 1X8

3. University Health Network, Toronto General Hospital, Toronto, ON, Canada, M5G 2C4

Status: Recruiting