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.

An Open-label, Multi-center, Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Are Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Are Available.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Polycythemia Vera

Interventions

Type	Name	Description
DRUG	Ruxolitinib	supplied as 5 mg, 10 mg and 20 mg tablets to be taken orally

Timeline

• Start date: 2014-11-21
• Primary completion: 2017-12-29
• Completion: 2017-12-29
• First posted: 2014-11-17
• Last updated: 2019-07-18
• Results posted: 2019-04-02

Locations

65 sites across 12 countries: Austria, Belgium, Bulgaria, Canada, Chile, France, Germany, Mexico, Norway, Portugal, Sweden, Thailand