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GMI-1070 Phase III - Rivipansel for Sickle Cell Disease Pain Crisis - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if the medicine Rivipansel is safe and if it will help people who have sickle cell disease during a pain crisis

What is the Condition Being Studied?

Sickle Cell Disease with Vaso-Occlusive Crisis (Pain Crisis)

Who Can Participate in the Study?

- Adults and children over 6 years of age
- Active pain crisis requiring you to go to the hospital

Age Group
Adults, Children

What is Involved?

If you agree to take part in this study, you will:
- Be in the study for 44 days
- Be randomized (like the flip of a coin) to receive either a medicine called Rivipansel or placebo (sugar pill)
- Be given a handheld device (smartphone or tablet) to enter information throughout the entire study
- Be contacted by telephone 7 and 21 days after you leave the hospital
- Have a visit 35 days after you leave the hospital

Study Details

Full Title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate The Efficacy and Safety of Rivipansel (GMI-1070) in The Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects with Sickle Cell Disease
Principal Investigator
Hematologist
Protocol Number
IRB:PRO00054359
NCT:NCT02187003
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698