Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease

Phase 3 Terminated 154 enrolled GlycoMimetics Incorporated

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is an open label extension study in subjects with Sickle Cell Disease (SCD) who have completed the double blind Phase 3 study (B5201002).

Timeline

Start: 2015-12-16
Primary completion: 2019-11-15
Completion: 2019-11-15

Outcome

Outcome not reported

Stopped: “The B5201003 OLE study was terminated based on the failure of the 'parent" B5201002 study to meet its efficacy endpoints. Termination was not due to safety.”

Publications

Dampier CD, Telen MJ, Wun T, Brown RC, Desai P, El Rassi F, Fuh B, Kanter J, Pastore Y, Rothman J, Taylor JG, Readett D, Sivamurthy KM, Tammara B, Tseng LJ, Lozier JN, Thackray H, Magnani JL, Hassell KL; RESET Investigators. A randomized clinical trial of the efficacy and safety of rivipansel for sickle cell vaso-occlusive crisis. Blood. 2023 Jan 12;141(2):168-179. doi: 10.1182/blood.2022015797.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rivipansel	Small molecule	20 mg/kg	Intravenous
Subject	Rivipansel	Small molecule	840 mg	Intravenous