A Phase II Trial of Regadenoson in Sickle Cell Anemia
Status:
Completed
Trial end date:
2016-12-12
Target enrollment:
Participant gender:
Summary
This research study is a Phase II clinical trial, which tests the safety and effectiveness of
an investigational drug called Regadenoson (or Lexiscan) to learn whether the drug works in
treating a specific disease, in this case Sickle Cell Disease (SCD). "Investigational" means
that the drug is being studied. It also means that the FDA has not yet approved the drug for
your type of disease.
SCD is an inherited blood disorder that causes the red blood cells to change their shape from
a round shape to a half-moon/crescent or sickled shape. People who have SCD have a different
type of protein that carries oxygen in their blood (hemoglobin) than people without SCD. This
different type of hemoglobin makes the red blood cells change into crescent shape under
certain conditions. Sickle-shaped cells are a problem because they often get stuck in the
blood vessels blocking the flow of blood, and cause inflammation and injury to important
areas in the body.
Regadenoson (trade name Lexiscan) is a drug that may prevent this inflammation and injury
caused by the sickle shaped cells. This drug is approved by the FDA to be used as a fast
infusion during a heart stress test in people who are unable to exercise enough to put stress
on their heart by making the heart beat faster. Regadenoson has been studied as a long
infusion at this dose in adults, and no safety issues have been identified
(ClinicalTrials.gov Identifier: NCT01085201). This is the first study to look at patient
benefit with the long infusion of the drug. This drug has been used in laboratory experiments
and information from those other research studies suggests that this drug may help to protect
the body from damage caused by sickle-shaped cells in this research study.
In this research study, the investigators are specifically looking to see if Regadenoson is
an effective treatment for pain crises and acute chest syndrome in SCD.
Phase:
Phase 2
Details
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Baylor College of Medicine Boston Children's Hospital Boston Children’s Hospital Brigham and Women's Hospital Children's Hospital & Research Center Oakland Children's Hospital Medical Center, Cincinnati Duke University Johns Hopkins University La Jolla Institute for Allergy & Immunology Medical College of Wisconsin National Heart, Lung, and Blood Institute (NHLBI) UCSF Benioff Children's Hospital Oakland University of Illinois at Chicago Washington University School of Medicine Wayne State University