Novartis Pharmaceuticals is sponsoring a clinical research trial for males and females, ages 8-20 years with sickle cell anemia.
Sickle cell anemia is found in patients who have inherited a red blood cell disorder where their red blood cells are shaped like a crescent or sickle. Because these cells are abnormally shaped, they do not last as long as normal, round blood cells; this causes anemia. These sickle cells can also get caught in blood vessels, consequently causing a blockage in blood flow. This can result in pain and organ damage.
Sickle cell anemia is the most common and severe kind of sickle cell disease. Individuals with sickle cell disease have inherited one of the two abnormal genes which causes the body to make hemoglobin S; those with sickle cell anemia have inherited two hemoglobin S genes (Hemoglobin SS).
This study is designed to assess the effect that the drug canakinumab has on daily pain experienced by sickle cell anemia patients. The effects of canakinumab will be compared to the placebo drug effects.
If you are eligible and agree to participate in this study, you will receive either canakinumab (the study drug) or a placebo (an inactive drug used to compare its effects to effects of the tested drug) during the first 6 months, and then you will have the opportunity to receive the study drug, canakinumab for another 6 months.
To see if you may be eligible to participate in this study click here.
Patients who participate in this trial must meet the following requirements:
Must be between the ages of 8-20 years old
Must be diagnosed with sickle cell anemia (HbSS) or sickle beta thalassemia
Have experienced several pain crises within the past year
Have not received treatment involving red blood cell transfusion therapy within the past 3 months
Patients who are eligible and decide to enroll in this trial:
Will be given monthly doses of either the study drug or placebo via subcutaneous injection for the trial period
Will not be charged to participate
May receive compensation for time and travel costs
May withdraw from the trial at any time, for any reason
To see if there is a clinical study site near you click here.
Additional study locations may be listed as they open in the future.