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

Recruiting in Palo Alto (17 mi)

+95 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: GlycoMimetics Incorporated

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

Inclusion Criteria

Completion of Study B5201002.

Documented diagnosis of SCD.

At least 6 years of age.

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Treatment Details

Interventions

Rivipansel (Selectin Inhibitor)

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment1 Intervention

Includes one pediatric stratum (6-11 years old). Subjects 6 to 11 years of age or subjects who weigh 40 kg, will receive a loading dose of 40 mg/kg (maximum of 1680 mg) followed by a maintenance dose of 20 mg/kg (maximum of 840 mg).

Group II: Cohort 1Experimental Treatment1 Intervention

Includes one adult stratum (\>18 years old) and one pediatric stratum (12-17 years old). Subjects aged 12 and over who weigh \>40 kg, will receive a loading dose of 1680 mg followed by a maintenance dose of 840 mg.