Adenosine 2A Agonist Lexiscan in Children and Adults With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      Sickle cell 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)
      then people without SCD. This different type of hemoglobin makes the red blood cells change
      into a crescent shape under certain conditions. Sickle-shaped cells are a problem because
      they often get stuck in blood vessels blocking the flow of blood, and cause inflammation and
      injury to the important areas in the body. Lexiscan is 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 it beat faster. Lexiscan has never been studied
      in patients with SCD and has never been given as a long infusion.
    

Detailed description: 
      -  In this research study we are looking for the highest dose of Lexiscan that can be given
           safely to patients with SCD. There are 4 stages to this study. Each stage will look for
           the highest dose that can be given safely in the following situations: Stage 1: Lexiscan
           will be given through a 12 hours infusion to adults with SCD who are not having a pain
           crisis. Stage 2: Lexiscan will be given through a 24 hour infusion to adults with SCD
           who are not having a pain crisis. Stage 2b: Lexiscan will be given through a 48 hour
           infusion to adults with SCD who are not having a pain crisis. Stage 3: Lexiscan will be
           given through a 24 hour infusion to adults with SCD who are having a pain crisis. Stage
           4: Lexiscan will be given through a 24 hour infusion to children with SCD who are having
           a pain crisis. Stages 1-3 are now complete and closed to accrual. The study is now open
           to children ages 10-17 with SCD pain crisis (stage 4) only.

        -  When participants sign the consent form, they will be told what stage they will join.

        -  Participants in Stages 1, 2, and 2b will be given an infusion of the study drug at the
           time when they do not have a pain crisis. The infusion for Stage 1 participants will be
           12 hours long, followed by a 6-hour observation period. The infusion for Stage 2 will be
           24 hours long, followed by a 6-hour observation period. The infusion for Stage 2b will
           be 48 hours long, followed by a 6-hour observation period.

        -  Participants in Stages 3 and 4 will be given one infusion of the study drug when they
           are admitted to the hospital for a pain crisis. The infusion will be 24 hours long,
           followed by a 6-hour observation period. During the infusion, they will receive standard
           treatment for their pain crisis.

        -  Before the infusion the following procedures will be performed: Pulmonary function test
           (optional, Stage 1 only), blood test and vital signs.

        -  During the infusion the following procedures will be performed: heart rate and amount of
           oxygen in the blood will be monitored continuously, blood tests and blood pressure.

        -  During the observation period immediately following the infusion the following
           procedures will be performed: heart rate and amount of oxygen in the blood will be
           monitored continuously, blood tests, blood pressure and Pulmonary Function test
           (optional, Stage 1 only).
    

Intervention name(s): Lexiscan
Intervention type(s): Drug
Intervention description(s): Given as an infusion
Intervention MeSH terms: Regadenoson
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lexiscan