Safety and Efficacy of Eltrombopag at Escalated Doses
Status:
Completed
Trial end date:
2017-10-16
Target enrollment:
Participant gender:
Summary
Study rationale is based on the data that in previous clinical studies of eltrombopag in ITP
there are some patients who have been reported as non responders at the maximal approved dose
of 75 mg daily. The trend in both normal volunteers and in patients with ITP suggest and
increasing response rate with increased doses of eltrombopag up to a dose of 75mg. Previously
published data has shown no overt increase in toxicity in normal volunteers, oncology
patients and aplastic anemia patients treated with escalated doses as high or higher than
those proposed in this study.
It therefore seems possible that in ITP patients who did not respond to a dose of 75mg daily,
eltrombopag could be more effective at a higher dose. We propose a double blind randomized
controlled trial in ITP patients who have been defined as non-responders at the maximum dose
(75mg) of eltrombopag, assessing efficacy and toxicity at higher daily doses (100mg, 125 mg,
150 mg)