drugset / Trial / NCT02292446

Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Were Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Was Available.

NCT02292446

Phase 3 Completed 161 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this open-label, single arm, multi-center Expanded Treatment Protocol (ETP) was to provide early access to ruxolitinib and evaluate safety information in patients with polycythemia vera (PV) who were hydroxyurea (HU) resistant or intolerant and who had no other standard treatment option, nor did they qualify for another clinical study for PV

Timeline

Start
2014-11-21
Primary completion
2017-12-29
Completion
2017-12-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Ruxolitinib Small molecule 10 mg Oral