NCT02187003

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

A Phase 3, Multicenter ,Randomized, Double-Blind, Placebo-Controlled, Parallel-Group 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 345 (actual)
• Sponsor: Biossil Inc. · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anemia, Sickle Cell

Interventions

Type	Name	Description
DRUG	Rivipansel	Rivipansel (GMI-1070) will be infused intravenously every 12 hours up to 15 doses maximum. Subjects aged 12 and over who weigh more than 40 kilograms will receive a dose of 1680 mg of rivipansel, followed by a dose of 840 mg of rivipansel every 12 hours. All subjects aged 6 to 11 years and any subject who weighs 40 kilograms or less, will receive weight-based dosing (mg/kg) of 40 mg/kg of rivipansel (maximum of 1680 mg) followed by a dose of 20 mg/kg of rivipansel (maximum of 840 mg) every 12 hours.
OTHER	Placebo	Placebo (phosphate buffered saline) will be infused intravenously every 12 hours up to 15 doses maximum.

Timeline

• Start date: 2015-06-17
• Primary completion: 2019-05-03
• Completion: 2019-06-27
• First posted: 2014-07-10
• Last updated: 2025-03-11
• Results posted: 2025-03-11

Locations

142 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study