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 HospitalizedSubjects with Sickle Cell Disease
Sponsor: |
Pfizer |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAQ2308 |
U.S. Govt. ID: |
NCT02187003 |
Contact: |
Margaret Lee, MD: 212-305-9770 / ml653@cumc.columbia.edu |
This study is for patients with sickle cell disease (SCD). SCD is an inherited genetic disorder in which red blood cells become abnormally shaped (sickle cells). These sickle cells may block blood vessels and result in a vaso occlusive crisis (VOC). This leads to inflammation and tissue damage and causes pain in various parts of the body. The purpose of this current research study is to compare the study drug, rivipansel, with a placebo in a larger number of subjects to find out if rivipansel is safe and effective for treating pain crisis in hospitalized subjects with SCD. Researchers use a placebo to see if the study drug works better than not taking anything and to compare the safety of the study drug with not taking anything.
This study is closed
Investigator
Margaret Lee, MD
Have you or your child been diagnosed with sickle cell disease? |
Yes |
No |