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

Completed · Phase 3 · Has a placebo group

Conditions studied: Anemia, Sickle Cell

In brief

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.

Key facts

Study ID

NCT02187003

Run by

Biossil Inc.

People needed

345

Starts

2015-06-17

Expected to finish

2019-06-27

Last updated by the study team

2025-03-11

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Arkansas Children's Hospital Research Pharmacy — Little Rock, Arkansas, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
• UC Davis Medical Center Main Hospital — Sacramento, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• University of Colorado CTRC — Aurora, Colorado, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Howard University Center for Sickle Cell Disease — Washington D.C., District of Columbia, United States
• Medstar Health Research Institute — Washington D.C., District of Columbia, United States
• Howard University Hospital — Washington D.C., District of Columbia, United States
• Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States
• UF Health Davis Cancer Pavillion and Shands Med Plaza — Gainesville, Florida, United States
• UF Health Shands Cancer Hospital — Gainesville, Florida, United States
• UF Health Shands Hospital — Gainesville, Florida, United States
• Jackson Memorial Hospital — Miami, Florida, United States
• University Of Miami — Miami, Florida, United States
• Investigational Drug Service Tampa General Hospital — Tampa, Florida, United States
• Tampa General Hospital Center of Research Excellence — Tampa, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• University of South Florida — Tampa, Florida, United States
• St. Joseph's Children's Hospital — Tampa, Florida, United States
• Children's Hematology and Oncology Associates — West Palm Beach, Florida, United States
• St. Mary's Medical Center — West Palm Beach, Florida, United States
• University of South Alabama Children's and Women's Hospital — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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