Essential Thrombocythaemia (rescue, orphan, registry)
The sponsor an essential thrombocythaemia study did not like the performance of their CRO (a top 5 company) and selected Pharm-Olam for a complete handover of a phase IIIb and phase IV registry in the same indication.
Patients could not have been previously treated with a cytoreductive agent and or have taken on any anti-coagulant and anti-aggregant therapies.
The phase IIIb study involved 14 countries in Western and Eastern Europe with 22 sites and 180 patients. The phase IV registry study involved 146 sites in 13 countries. 3,668 high-risk ET patients taking cytoreductive therapy were enrolled in 18 months.
The sponsor was pleased with our performance and has since awarded Pharm-Olam a third study in pediatrics.