At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 149 enrolled

Drug / intervention

Best Available Therapy +1 moredrug

Likely dose

Ruxolitinib 10 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.

Search/NCT02038036

NCT02038036Phase 3Completed

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Randomized, Open Label, Multicenter Phase IIIb Study Evaluating the Efficacy and Safety of Ruxolitinib Versus Best Available Therapy in Patients With Polycythemia Vera Who Are Hydroxyurea Resistant or Intolerant (Response 2)

Novartis Pharmaceuticals·interventional·Posted Jan 16, 2014·Updated Jul 20, 2021

In Brief

A Phase 3 clinical trial evaluating Best Available Therapy and Ruxolitinib for Polycythemia Vera. Completed, enrolled 149 participants across 48 sites in 12 countries.

Detailed Summary

This study compared the efficacy and safety of ruxolitinib to Best Available Therapy (BAT) in patients with polycythemia vera (PV) who were hydroxyurea (HU) resistant or intolerant and did not have a palpable spleen.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPolycythemia Vera

CountriesAustralia, Belgium, Canada, France, Germany, Hungary, India, Israel, Italy, South Korea, Spain, Turkey (Türkiye)

Collaborators--

Timeline

Phase 3CompletedFinished

2014201520162017201820192020202120222023202420252026

First PostedJan 2014

Enrollment StartMar 2014

Primary CompletionSep 2015

Study CompletionApr 2020

TodayJul 2026

First PostedJan 16, 2014

Enrollment StartMar 25, 2014

Primary CompletionSep 29, 2015

Study CompletionApr 7, 2020

TodayJul 2, 2026

Enrollment to primary: 1.5 yearsPosted 12.5 years ago

Interventions

Best Available Therapydrug

Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib.

Ruxolitinibdrug

Ruxolitinib was administered at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid.