Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease
NCT02433158 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 154
Last updated 2021-02-10
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).
Conditions
- Sickle Cell Anemia
- Sickle Cell Disease
- Sickle Cell Disorders
- Pain Crisis
- Vaso-occlusive Crisis
Interventions
- DRUG
-
Rivipansel
Rivipansel will be infused intravenously every 12 hours up to a maximum of 15 doses.
Sponsors & Collaborators
-
GlycoMimetics Incorporated
lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-12-16
- Primary Completion
- 2019-11-15
- Completion
- 2019-11-15
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
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