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.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02292446
Phase
PHASE3
Status
Completed

Conditions

  • Polycythemia Vera

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    supplied as 5 mg, 10 mg and 20 mg tablets to be taken orally

Study Details

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

Key Dates

Start date
Nov 21, 2014
Status verified
Jul 2019
Primary completion
Dec 29, 2017
Completion
Dec 29, 2017

Study Design

Enrollment
161 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All patients
    All patients will receive ruxolitinib at a starting dose of 10 mg twice daily which could be titrated to most appropriate dose. Dose was not to exceed 25 mg bid nor be less than 5 mg once a day

Primary Outcome Measure

Number of Participants With Adverse Events - All Grades [ Time Frame: Baseline up to approximately 26 months ]

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