Safety Study of Eltrombopag Combined With Azacitidine to Treat Myelodysplastic Syndrome (MDS)
Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
Summary
Patients with Myelodysplastic Syndromes (MDS) often suffer from low platelet levels which may
lead to bleeding complications. Treatment with cytotoxic agents can decrease the platelet
levels further. Eltrombopag is a relatively new drug that increases the platelet level in the
blood by working directly on the bone marrow. It is available for treatment of the disease
Immunological Thrombocytopenic Purpura (ITP). In this study patients with MDS and low
platelet levels that are treated with the cytotoxic agent Azacitidine will also receive
Eltrombopag. The administration of Eltrombopag to MDS patients treated with Azacitidine may
result in less dose reductions and less treatment delays for Azacitidine and may reduce the
need for thrombocyte transfusions and lower the risk of bleeding complications.
This is a phase I study, meaning that our major goal is to investigate the safety and
tolerability for Eltrombopag in this patient group. It will also generate a basis for a phase
II-III-study.