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

Stopped early · Phase 3

Conditions studied: Sickle Cell Anemia, Sickle Cell Disease, Sickle Cell Disorders, Pain Crisis, Vaso-occlusive Crisis

In brief

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

Key facts

Study ID

NCT02433158

Run by

GlycoMimetics Incorporated

People needed

154

Starts

2015-12-16

Expected to finish

2019-11-15

Last updated by the study team

2021-02-10

Who can join

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

You may qualify if…

• Completion of Study B5201002.
• Documented diagnosis of SCD.
• At least 6 years of age.
• Male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study.
• Diagnosis of VOC necessitating IV opioids and admission to the hospital.
• Able to receive the first dose of rivipansel within 24 hours from administration of the first dose of IV opioids for this hospitalization.

You may not qualify if…

• Non-compliance with study procedures in the double blind study (B5201002).
• Occurrence of any severe and/or generalized cutaneous manifestation or any other adverse event during participation in Study B5201002 that was related to study drug and which would therefore make it inappropriate for the subject to receive rivipansel in the current study.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results.
• Clinically significant deterioration in renal function in Study B5201002.
• Pregnant female subjects, breastfeeding female subjects and male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception.
• Active use of illicit drugs and/or alcohol dependence.

Where it is running

• Arkansas Children's Hospital Research Pharmacy — Little Rock, Arkansas, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• UC Davis Medical Center Main Hospital — Sacramento, California, United States
• University of California Davis Medical Center — Sacramento, California, 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 Childrens Hospital of Southwest Florida — Fort Myers, Florida, United States
• Jackson Memorial Hospital — Miami, Florida, United States
• University of Miami — Miami, Florida, United States
• St. Mary's Medical Center — West Palm Beach, Florida, United States
• Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center: — Atlanta, Georgia, United States
• Grady Health System — Atlanta, Georgia, United States
• Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center: — Atlanta, Georgia, United States
• Emory Children's Center — Atlanta, Georgia, United States
• Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center/ — Atlanta, Georgia, United States
• Children's Healthcare of Atlanta: Scottish Rite Campus — Atlanta, Georgia, United States
• Memorial Family Medicine Center — Savannah, Georgia, United States
• Memorial Health University Medical Center — Savannah, Georgia, United States
• The University of Chicago/Comer Children's Hospital — Chicago, Illinois, United States
• University of Chicago, Investigational Drug Service Pharmacy — Chicago, Illinois, United States
• University of Maryland Medical System Investigational Pharmacy — Baltimore, Maryland, United States
• University of Maryland Medical System — Baltimore, Maryland, United States
• Johns Hopkins Department of Medicine Clinical Trials Unit — Baltimore, Maryland, United States
• University of South Alabama Women's and Children's Hospital — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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