Status:
COMPLETED
Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease
Lead Sponsor:
Biossil Inc.
Collaborating Sponsors:
GlycoMimetics Incorporated
Conditions:
Anemia, Sickle Cell
Eligibility:
All Genders
6+ years
Phase:
PHASE3
Brief 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 nece...
Eligibility Criteria
Inclusion
- At least 6 years of age.
- Documented diagnosis of sickle cell disease.
- Diagnosis of vaso-occlusive crisis necessitating admission to the hospital with treatment including IV opioids.
- Able to receive the first dose of study drug within 24 hours from the administration of IV opioids.
Exclusion
- Serious systemic infection
- Acute Chest Syndrome
- Serious concomitant medical problems (for example, stroke)
- SCD pain atypical of VOC
- Severe renal or hepatic impairment
- Chronic pain rather than a presentation of acute VOC
Key Trial Info
Start Date :
June 17 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2019
Estimated Enrollment :
345 Patients enrolled
Trial Details
Trial ID
NCT02187003
Start Date
June 17 2015
End Date
June 27 2019
Last Update
March 11 2025
Active Locations (142)
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1
University of South Alabama Children's and Women's Hospital
Mobile, Alabama, United States, 36604
2
Arkansas Children's Hospital Research Pharmacy
Little Rock, Arkansas, United States, 72202
3
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
4
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609