At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 161 enrolled
Drug / intervention
Ruxolitinibdrug
Likely dose
Ruxolitinib 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating Ruxolitinib for Polycythemia Vera. Completed, enrolled 161 participants across 65 sites in 12 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolycythemia Vera
CountriesAustria, Belgium, Bulgaria, Canada, Chile, France, Germany, Mexico, Norway, Portugal, Sweden, Thailand
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 2014
Enrollment StartNov 2014
Primary CompletionDec 2017
TodayJul 2026
First PostedNov 17, 2014
Enrollment StartNov 21, 2014
Primary CompletionDec 29, 2017
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 11.6 years ago
Interventions
Ruxolitinibdrug
supplied as 5 mg, 10 mg and 20 mg tablets to be taken orally